Trial Outcomes & Findings for Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction (NCT NCT04622735)
NCT ID: NCT04622735
Last Updated: 2024-11-27
Results Overview
Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
6 hours post-dose
Results posted on
2024-11-27
Participant Flow
Participant milestones
| Measure |
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Nefopam Hydrochloride 30 mg (X2)
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
107
|
108
|
106
|
|
Overall Study
COMPLETED
|
105
|
106
|
104
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Nefopam Hydrochloride 30 mg (X2)
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=107 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=321 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=107 Participants
|
108 Participants
n=108 Participants
|
106 Participants
n=106 Participants
|
321 Participants
n=321 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=321 Participants
|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
28.3 years
STANDARD_DEVIATION 7.9 • n=108 Participants
|
28.3 years
STANDARD_DEVIATION 7.8 • n=106 Participants
|
28.1 years
STANDARD_DEVIATION 7.8 • n=321 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=107 Participants
|
61 Participants
n=108 Participants
|
61 Participants
n=106 Participants
|
184 Participants
n=321 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=107 Participants
|
47 Participants
n=108 Participants
|
45 Participants
n=106 Participants
|
137 Participants
n=321 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
8 Participants
n=107 Participants
|
9 Participants
n=108 Participants
|
7 Participants
n=106 Participants
|
24 Participants
n=321 Participants
|
|
Region of Enrollment
Hungary
|
33 Participants
n=107 Participants
|
31 Participants
n=108 Participants
|
33 Participants
n=106 Participants
|
97 Participants
n=321 Participants
|
|
Region of Enrollment
United Kingdom
|
30 Participants
n=107 Participants
|
30 Participants
n=108 Participants
|
31 Participants
n=106 Participants
|
91 Participants
n=321 Participants
|
|
Region of Enrollment
France
|
19 Participants
n=107 Participants
|
18 Participants
n=108 Participants
|
19 Participants
n=106 Participants
|
56 Participants
n=321 Participants
|
|
Region of Enrollment
Russia
|
17 Participants
n=107 Participants
|
20 Participants
n=108 Participants
|
16 Participants
n=106 Participants
|
53 Participants
n=321 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-dosePain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)
|
5290.7 score on a scale
Standard Deviation 9109.3
|
8955.4 score on a scale
Standard Deviation 8751.8
|
8458.0 score on a scale
Standard Deviation 8831.7
|
PRIMARY outcome
Timeframe: 6 hours post-dosePain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS). Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Total Pain Relief at 6 Hours (TOTPAR0-6h)
|
461.4 score on a scale
Standard Deviation 384.5
|
610.6 score on a scale
Standard Deviation 434.5
|
602.2 score on a scale
Standard Deviation 383.6
|
PRIMARY outcome
Timeframe: 6 hours post-doseA responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Proportion of Responder Patients
|
35 Participants
|
47 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=101 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=104 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=100 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
MUCH WORSE
|
8 Participants
|
7 Participants
|
9 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
VERY MUCH WORSE
|
1 Participants
|
1 Participants
|
0 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
VERY MUCH IMPROVED
|
11 Participants
|
11 Participants
|
14 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
MUCH IMPROVED
|
30 Participants
|
39 Participants
|
29 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
MINIMALLY IMPROVED
|
31 Participants
|
22 Participants
|
24 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
NO CHANGE
|
13 Participants
|
14 Participants
|
12 Participants
|
|
The Patient's Global Impression of Change (PGIC) Questionnaire
MINIMALLY WORSE
|
7 Participants
|
10 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: during the first 6 hoursScore of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
The Onset of Pain Relief
|
58 Participants
|
76 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: At 1 hour, 2 hours, 3 hours, and 4 hoursPain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
TOTPAR0-1h
|
49.7 score on a scale
Standard Deviation 47.7
|
60.2 score on a scale
Standard Deviation 54.2
|
69.4 score on a scale
Standard Deviation 49.5
|
|
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
TOTPAR0-2h
|
133.2 score on a scale
Standard Deviation 116.9
|
170.0 score on a scale
Standard Deviation 130.6
|
183.0 score on a scale
Standard Deviation 115.7
|
|
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
TOTPAR0-3h
|
216.3 score on a scale
Standard Deviation 185.7
|
285.4 score on a scale
Standard Deviation 210.5
|
300.8 score on a scale
Standard Deviation 184.7
|
|
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
TOTPAR0-4h
|
298.4 score on a scale
Standard Deviation 254.4
|
399.7 score on a scale
Standard Deviation 288.4
|
412.2 score on a scale
Standard Deviation 252.2
|
SECONDARY outcome
Timeframe: At 1 hour, 2 hours, 3 hours, and 4 hoursPID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline. Calculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP SPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
SPID0-1h
|
506.4 score on a scale
Standard Deviation 1042.5
|
743.7 score on a scale
Standard Deviation 1075.2
|
809.5 score on a scale
Standard Deviation 1017.3
|
|
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
SPID0-2h
|
1487.2 score on a scale
Standard Deviation 2723.5
|
2405.9 score on a scale
Standard Deviation 2553.0
|
2418.4 score on a scale
Standard Deviation 2469.2
|
|
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
SPID0-3h
|
2486.8 score on a scale
Standard Deviation 4425.5
|
4281.3 score on a scale
Standard Deviation 4071.1
|
4128.8 score on a scale
Standard Deviation 4022.0
|
|
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
SPID0-4h
|
3467.2 score on a scale
Standard Deviation 6054.1
|
6039.8 score on a scale
Standard Deviation 5636.4
|
5786.0 score on a scale
Standard Deviation 5639.1
|
SECONDARY outcome
Timeframe: At each timepoint: 30min, At 45min, until at 360 min post-dosePID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline. PID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
The Pain Intensity Differences (PID) Assessment
30 min
|
-8.6 units on a scale
Standard Deviation 20.8
|
-11.4 units on a scale
Standard Deviation 22.6
|
-14.8 units on a scale
Standard Deviation 22.3
|
|
The Pain Intensity Differences (PID) Assessment
45 min
|
-12.7 units on a scale
Standard Deviation 25.9
|
-20.1 units on a scale
Standard Deviation 27
|
-19.6 units on a scale
Standard Deviation 24.6
|
|
The Pain Intensity Differences (PID) Assessment
360 min
|
-14.6 units on a scale
Standard Deviation 29.2
|
-20.2 units on a scale
Standard Deviation 30.2
|
-18.0 units on a scale
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: At 1 hour, 2 hours, 3 hours and 4 hours.Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Proportion of Responder Patients.
RESPONDER AT 1 HOUR,
|
34 Participants
|
44 Participants
|
45 Participants
|
|
Proportion of Responder Patients.
RESPONDER AT 2 HOUR,
|
38 Participants
|
57 Participants
|
54 Participants
|
|
Proportion of Responder Patients.
RESPONDER AT 3 HOUR,
|
34 Participants
|
61 Participants
|
53 Participants
|
|
Proportion of Responder Patients.
RESPONDER AT 4 HOUR,
|
37 Participants
|
54 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Time to the Second Investigational Medicinal Product (IMP) Intake
|
387.0 minutes
Interval 375.0 to 435.0
|
438.5 minutes
Interval 400.0 to 495.0
|
429.0 minutes
Interval 385.0 to 480.0
|
SECONDARY outcome
Timeframe: Up to 10 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Participant Having Taken a Rescue Analgesic Treatment
|
35 Participants
|
19 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At days 1, 2, 3, 4 and 5Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline. Calculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product With: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Sum of Pain Intensity Differences
SPID Day 5
|
78299.5 score on a scale
Standard Deviation 106041.1
|
92644.0 score on a scale
Standard Deviation 96128.8
|
96134.2 score on a scale
Standard Deviation 107774.7
|
|
Sum of Pain Intensity Differences
SPID Day 1
|
19910.3 score on a scale
Standard Deviation 28416.2
|
23306.5 score on a scale
Standard Deviation 23707.8
|
22173.7 score on a scale
Standard Deviation 25105.0
|
|
Sum of Pain Intensity Differences
SPID Day 2
|
42972.1 score on a scale
Standard Deviation 52821.9
|
48792.4 score on a scale
Standard Deviation 48167.2
|
44604.7 score on a scale
Standard Deviation 48227.7
|
|
Sum of Pain Intensity Differences
SPID Day 3
|
61347.0 score on a scale
Standard Deviation 75669.6
|
70094.2 score on a scale
Standard Deviation 70059.9
|
68351.5 score on a scale
Standard Deviation 71111.0
|
|
Sum of Pain Intensity Differences
SPID Day 4
|
73960.7 score on a scale
Standard Deviation 96674.9
|
84261.6 score on a scale
Standard Deviation 84118.3
|
84781.0 score on a scale
Standard Deviation 90576.9
|
SECONDARY outcome
Timeframe: Up to 10 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.
|
35 Participants
|
19 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 10 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=35 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=19 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=26 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
The Total Dose of Rescue Medication Taken.
|
6.0 mg
Standard Deviation 4.0
|
7.1 mg
Standard Deviation 5.2
|
7.3 mg
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Up to 5 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=34 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=19 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=26 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Mean Duration Under Rescue Medication Over the 5 Days.
|
61.9 hours
Standard Deviation 42.2
|
57.9 hours
Standard Deviation 51.5
|
99.4 hours
Standard Deviation 144.5
|
SECONDARY outcome
Timeframe: Up to 5 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Number of Investigational Medicinal Product (IMP) Intakes
|
5.1 intake
Standard Deviation 3.6
|
6.4 intake
Standard Deviation 4.5
|
5.8 intake
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Up to 10 days after first doseOutcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Patient's Global Impression of Change (PGIC) Score
MINIMALLY WORSE
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
VERY MUCH IMPROVED
|
34 Participants
|
36 Participants
|
39 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
MUCH IMPROVED
|
40 Participants
|
40 Participants
|
46 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
MINIMALLY IMPROVED
|
16 Participants
|
11 Participants
|
9 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
NO CHANGE
|
5 Participants
|
9 Participants
|
4 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
MUCH WORSE
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
VERY MUCH WORSE
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Patient's Global Impression of Change (PGIC) Score
Missing
|
7 Participants
|
5 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 days after first dosePopulation: All population has been analysed
= Number of Events
Outcome measures
| Measure |
Nefopam Hydrochloride 30 mg (X2)
n=106 Participants
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 Participants
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 Participants
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Occurrence of Adverse Events (Serious and Non-serious Adverse Events).
|
35 Adverse Event
|
39 Adverse Event
|
25 Adverse Event
|
Adverse Events
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Paracetamol 500 mg (X2)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Nefopam Hydrochloride 30 mg (X2)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)
n=107 participants at risk
Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Paracetamol 500 mg (X2)
n=108 participants at risk
Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
Nefopam Hydrochloride 30 mg (X2)
n=106 participants at risk
Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Cardiac disorders
PALPITATIONS
|
1.9%
2/107 • Number of events 3 • 10 days
|
0.00%
0/108 • 10 days
|
1.9%
2/106 • Number of events 2 • 10 days
|
|
Cardiac disorders
TACHYCARDIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
1.9%
2/106 • Number of events 2 • 10 days
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Ear and labyrinth disorders
MOTION SICKNESS
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
NAUSEA
|
12.1%
13/107 • Number of events 14 • 10 days
|
7.4%
8/108 • Number of events 8 • 10 days
|
12.3%
13/106 • Number of events 13 • 10 days
|
|
Gastrointestinal disorders
VOMITIN
|
1.9%
2/107 • Number of events 2 • 10 days
|
0.00%
0/108 • 10 days
|
1.9%
2/106 • Number of events 2 • 10 days
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.8%
3/107 • Number of events 3 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Gastrointestinal disorders
RETCHING
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
General disorders
PYREXIA
|
2.8%
3/107 • Number of events 3 • 10 days
|
2.8%
3/108 • Number of events 3 • 10 days
|
4.7%
5/106 • Number of events 5 • 10 days
|
|
General disorders
FATIGUE
|
2.8%
3/107 • Number of events 3 • 10 days
|
1.9%
2/108 • Number of events 2 • 10 days
|
3.8%
4/106 • Number of events 4 • 10 days
|
|
General disorders
SWELLING FACE
|
0.93%
1/107 • Number of events 1 • 10 days
|
1.9%
2/108 • Number of events 2 • 10 days
|
1.9%
2/106 • Number of events 2 • 10 days
|
|
General disorders
ASTHENIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
1.9%
2/108 • Number of events 2 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
General disorders
CHILLS
|
2.8%
3/107 • Number of events 3 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
General disorders
FEELING HOT
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
General disorders
ILLNESS
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Infections and infestations
ALVEOLAR OSTEITIS
|
1.9%
2/107 • Number of events 3 • 10 days
|
2.8%
3/108 • Number of events 3 • 10 days
|
3.8%
4/106 • Number of events 4 • 10 days
|
|
Infections and infestations
WOUND INFECTION
|
1.9%
2/107 • Number of events 2 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Infections and infestations
ABSCESS
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Infections and infestations
RHINITIS
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 2 • 10 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL OEDEMA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Injury, poisoning and procedural complications
PROCEDURAL VOMITING
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Investigations
HEART RATE INCREASED
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Musculoskeletal and connective tissue disorders
TRISMUS
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Nervous system disorders
HEADACHE
|
3.7%
4/107 • Number of events 5 • 10 days
|
4.6%
5/108 • Number of events 5 • 10 days
|
6.6%
7/106 • Number of events 7 • 10 days
|
|
Nervous system disorders
DIZZINESS
|
5.6%
6/107 • Number of events 6 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
7.5%
8/106 • Number of events 8 • 10 days
|
|
Nervous system disorders
SOMNOLENCE
|
6.5%
7/107 • Number of events 7 • 10 days
|
3.7%
4/108 • Number of events 4 • 10 days
|
1.9%
2/106 • Number of events 2 • 10 days
|
|
Nervous system disorders
PRESYNCOPE
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Nervous system disorders
DYSGEUSIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Nervous system disorders
SYNCOPE
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Nervous system disorders
TREMOR
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Psychiatric disorders
INSOMNIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Renal and urinary disorders
CHROMATURIA
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 2 • 10 days
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
3.7%
4/107 • Number of events 4 • 10 days
|
1.9%
2/108 • Number of events 2 • 10 days
|
2.8%
3/106 • Number of events 3 • 10 days
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/107 • 10 days
|
0.93%
1/108 • Number of events 1 • 10 days
|
0.00%
0/106 • 10 days
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/107 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
|
Skin and subcutaneous tissue disorders
HOT FLUSH
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.94%
1/106 • Number of events 1 • 10 days
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
0.93%
1/107 • Number of events 1 • 10 days
|
0.00%
0/108 • 10 days
|
0.00%
0/106 • 10 days
|
Additional Information
Non Clinical & Clinical Project Manager
Unither Pharmaceuticals
Phone: +33 (0)1 44 63 51 78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60