Trial Outcomes & Findings for Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy (NCT NCT00626886)
NCT ID: NCT00626886
Last Updated: 2021-01-11
Results Overview
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 24 Hour - number count - higher score means worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
0 to 24 hours postoperatively
Results posted on
2021-01-11
Participant Flow
Investigative medical sites
Participant milestones
| Measure |
Bupivacaine Collagen Sponge
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
29
|
|
Overall Study
COMPLETED
|
24
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
Baseline characteristics by cohort
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 13.08 • n=99 Participants
|
52.6 years
STANDARD_DEVIATION 15.71 • n=107 Participants
|
49.6 years
STANDARD_DEVIATION 14.80 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
29 participants
n=107 Participants
|
53 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours postoperativelyPopulation: intent-to-treat
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 24 Hour - number count - higher score means worse outcome
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours
|
18.48 mg
Standard Deviation 12.65
|
24.60 mg
Standard Deviation 15.28
|
SECONDARY outcome
Timeframe: 0 to 48 hours postoperativelyPopulation: In the ITT population
Number count. Higher score means worse outcome
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Total Use of Opioid Rescue Analgesia Over 0 to 48 Hours
|
30.60 mg
Standard Deviation 19.880
|
36.50 mg
Standard Deviation 25.405
|
SECONDARY outcome
Timeframe: 0 to 72 hours postoperativelyNumber count - higher score means worse outcome
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Total Use of Opioid Rescue Analgesia Over 0 to 72 Hours
|
37.20 mg
Standard Deviation 29.296
|
44.89 mg
Standard Deviation 35.037
|
SECONDARY outcome
Timeframe: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0Population: In the ITT population using the mWOCF method of imputation, the differences in the mean summed pain intensity (SPI) VAS at-rest score
Summed pain intensity (SPI) (VAS at rest and after cough): - For the VAS assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor. Each timepoint consist of two measurements (Resting \& Coughing) - The lower the score the better outcome for the patient. The highest total score (worst possible score) for the 10 timepoints would be 2000.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
1 to 24 hours
|
413.8 score on a scale
Standard Deviation 283.84
|
862.0 score on a scale
Standard Deviation 573.16
|
|
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
25 to 48 hours
|
395.0 score on a scale
Standard Deviation 360.31
|
594.6 score on a scale
Standard Deviation 580.27
|
|
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
49 to 72 hours
|
251.5 score on a scale
Standard Deviation 217.11
|
426.6 score on a scale
Standard Deviation 488.03
|
|
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
1 to 72 hours
|
1060.3 score on a scale
Standard Deviation 788.62
|
1883.3 score on a scale
Standard Deviation 1585.58
|
SECONDARY outcome
Timeframe: At 72 hours after time 0For the 5-point categorical scale global evaluation of study treatment, the patient was instructed to score his global evaluation of the pain control provided by the study treatment where: 0 = poor, 1 = fair, 2 = good, 3 = very good and 4 = excellent
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Excellent,
|
12 Participants
|
14 Participants
|
|
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Very good,
|
8 Participants
|
9 Participants
|
|
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Good,
|
3 Participants
|
3 Participants
|
|
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Fair
|
1 Participants
|
2 Participants
|
|
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Poor
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 1, 1.5, 2,3,4,5,6,24,48,72 HoursPopulation: Intent-to-Treat Population
For the VAS assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
VAS Pain Intensity Scores Over Time
Hour 1.0
|
32.8 units on a scale
Standard Deviation 21.82
|
48.2 units on a scale
Standard Deviation 48.2
|
|
VAS Pain Intensity Scores Over Time
Hour 1.5
|
30.3 units on a scale
Standard Deviation 15.37
|
52.9 units on a scale
Standard Deviation 25.66
|
|
VAS Pain Intensity Scores Over Time
Hour 2.0
|
26.8 units on a scale
Standard Deviation 16.50
|
49.6 units on a scale
Standard Deviation 27.17
|
|
VAS Pain Intensity Scores Over Time
Hour 3.0
|
21.2 units on a scale
Standard Deviation 13.45
|
45.6 units on a scale
Standard Deviation 23.16
|
|
VAS Pain Intensity Scores Over Time
Hour 4.0
|
18.5 units on a scale
Standard Deviation 13.51
|
40.8 units on a scale
Standard Deviation 27.52
|
|
VAS Pain Intensity Scores Over Time
Hour 5.0
|
17.2 units on a scale
Standard Deviation 15.25
|
40.8 units on a scale
Standard Deviation 29.78
|
|
VAS Pain Intensity Scores Over Time
Hour 6.0
|
14.6 units on a scale
Standard Deviation 13.94
|
41.6 units on a scale
Standard Deviation 28.53
|
|
VAS Pain Intensity Scores Over Time
Hour 24
|
18.7 units on a scale
Standard Deviation 20.52
|
29.3 units on a scale
Standard Deviation 28.66
|
|
VAS Pain Intensity Scores Over Time
Hour 48
|
14.2 units on a scale
Standard Deviation 12.52
|
20.2 units on a scale
Standard Deviation 21.89
|
|
VAS Pain Intensity Scores Over Time
Hour 72
|
6.8 units on a scale
Standard Deviation 7.63
|
15.3 units on a scale
Standard Deviation 19.73
|
SECONDARY outcome
Timeframe: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hoursPopulation: Intent-to-Treat Population
For the 4-point categorical scale assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 0.5
|
1.0 score on a scale
Standard Deviation 0.87
|
1.3 score on a scale
Standard Deviation 1.11
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 1.0
|
1.6 score on a scale
Standard Deviation 0.66
|
1.8 score on a scale
Standard Deviation 0.67
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 1.5
|
1.4 score on a scale
Standard Deviation 0.58
|
1.8 score on a scale
Standard Deviation 0.71
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 2.0
|
1.2 score on a scale
Standard Deviation 0.51
|
1.8 score on a scale
Standard Deviation 0.68
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 3.0
|
1.3 score on a scale
Standard Deviation 0.53
|
1.7 score on a scale
Standard Deviation 0.70
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 4.0
|
1.0 score on a scale
Standard Deviation 0.47
|
1.6 score on a scale
Standard Deviation 0.78
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 5.0
|
1.1 score on a scale
Standard Deviation 0.51
|
1.7 score on a scale
Standard Deviation 0.77
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 6.0
|
1.0 score on a scale
Standard Deviation 0.47
|
1.6 score on a scale
Standard Deviation 0.78
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 24
|
1.1 score on a scale
Standard Deviation 0.65
|
1.3 score on a scale
Standard Deviation 0.93
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 48
|
1.0 score on a scale
Standard Deviation 0.62
|
1.0 score on a scale
Standard Deviation 0.80
|
|
Categorical Pain Intensity Scores Over Time - AT REST
Hour 72
|
0.7 score on a scale
Standard Deviation 0.56
|
0.7 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hoursPopulation: Intent-to-Treat Population
For the 5-point categorical scale assessment of pain relief, the patient was instructed to score his pain relief using a numerical scale where: 0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief and 4 = complete relief.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 0.5
|
1.8 score on a scale
Standard Deviation 1.20
|
1.6 score on a scale
Standard Deviation 1.13
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 1.0
|
1.9 score on a scale
Standard Deviation 0.76
|
1.6 score on a scale
Standard Deviation 1.06
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 1.5
|
1.9 score on a scale
Standard Deviation 0.83
|
1.5 score on a scale
Standard Deviation 1.06
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 2.0
|
2.0 score on a scale
Standard Deviation 1.00
|
1.6 score on a scale
Standard Deviation 0.91
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 3.0
|
2.3 score on a scale
Standard Deviation 0.81
|
2.0 score on a scale
Standard Deviation 0.94
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 4.0
|
2.3 score on a scale
Standard Deviation 0.83
|
2.0 score on a scale
Standard Deviation 1.00
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 5.0
|
2.3 score on a scale
Standard Deviation 0.93
|
2.0 score on a scale
Standard Deviation 0.98
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 6.0
|
2.5 score on a scale
Standard Deviation 0.99
|
2.1 score on a scale
Standard Deviation 0.94
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 24
|
2.3 score on a scale
Standard Deviation 0.9
|
2.4 score on a scale
Standard Deviation 1.02
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 48
|
2.5 score on a scale
Standard Deviation 0.93
|
2.8 score on a scale
Standard Deviation 0.95
|
|
Categorical Pain Relief Scores Over Time - AT REST
Hour 72
|
3.0 score on a scale
Standard Deviation 0.93
|
3.0 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hoursPopulation: Intent-to-Treat Population
For the 4-point categorical scale assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe." Higher Score means a worse outcome
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 4.0
|
1.4 score on a scale
Standard Deviation 0.59
|
2.0 score on a scale
Standard Deviation 0.65
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 5.0
|
1.4 score on a scale
Standard Deviation 0.78
|
2.0 score on a scale
Standard Deviation 0.73
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 6.0
|
1.2 score on a scale
Standard Deviation 0.58
|
2.0 score on a scale
Standard Deviation 0.91
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 0.5
|
1.2 score on a scale
Standard Deviation 0.97
|
1.3 score on a scale
Standard Deviation 1.11
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 1.0
|
1.8 score on a scale
Standard Deviation 0.78
|
2.1 score on a scale
Standard Deviation 0.77
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 1.5
|
1.6 score on a scale
Standard Deviation 0.58
|
2.1 score on a scale
Standard Deviation 0.64
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 2.0
|
1.6 score on a scale
Standard Deviation 0.65
|
2.2 score on a scale
Standard Deviation 0.66
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 3.0
|
1.5 score on a scale
Standard Deviation 0.66
|
2.0 score on a scale
Standard Deviation 0.68
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 24
|
1.4 score on a scale
Standard Deviation 0.65
|
1.8 score on a scale
Standard Deviation 0.74
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 48
|
1.3 score on a scale
Standard Deviation 0.61
|
1.4 score on a scale
Standard Deviation 0.57
|
|
Categorical Pain Intensity Scores Over Time (After Cough)
Hour 72
|
1.0 score on a scale
Standard Deviation 0.55
|
1.1 score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hoursPopulation: Intent-to-Treat Population
For the 5-point categorical scale assessment of pain relief, the patient was instructed to score his pain relief using a numerical scale where: 0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief and 4 = complete relief.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=24 Participants
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 Participants
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 72
|
2.9 score on a scale
Standard Deviation 0.95
|
2.7 score on a scale
Standard Deviation 0.76
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 0.5
|
1.8 score on a scale
Standard Deviation 1.20
|
1.6 score on a scale
Standard Deviation 1.13
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 1.0
|
1.5 score on a scale
Standard Deviation 0.90
|
1.3 score on a scale
Standard Deviation 0.79
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 1.5
|
1.8 score on a scale
Standard Deviation 0.87
|
1.4 score on a scale
Standard Deviation 1.01
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 2.0
|
1.8 score on a scale
Standard Deviation 0.92
|
1.2 score on a scale
Standard Deviation 0.93
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 3.0
|
2.1 score on a scale
Standard Deviation 0.78
|
1.7 score on a scale
Standard Deviation 0.88
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 4.0
|
.2 score on a scale
Standard Deviation 0.90
|
1.7 score on a scale
Standard Deviation 0.90
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 5.0
|
2.1 score on a scale
Standard Deviation 1.02
|
1.6 score on a scale
Standard Deviation 0.90
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 6.0
|
2.4 score on a scale
Standard Deviation 1.03
|
1.7 score on a scale
Standard Deviation 1.00
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 24
|
1.9 score on a scale
Standard Deviation 1.08
|
2.0 score on a scale
Standard Deviation 0.91
|
|
Categorical Pain Relief Scores Over Time (After Cough)
Hour 48
|
2.5 score on a scale
Standard Deviation 1.02
|
2.3 score on a scale
Standard Deviation 0.77
|
Adverse Events
Bupivacaine Collagen Sponge
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Collagen Sponge
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine Collagen Sponge
n=24 participants at risk
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 participants at risk
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Up to 30 days
|
0.00%
0/29 • Up to 30 days
|
|
Reproductive system and breast disorders
Hiccups
|
0.00%
0/24 • Up to 30 days
|
3.4%
1/29 • Number of events 1 • Up to 30 days
|
Other adverse events
| Measure |
Bupivacaine Collagen Sponge
n=24 participants at risk
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride
|
Placebo Collagen Sponge
n=29 participants at risk
Placebo collagen sponge implanted during surgery
placebo collagen sponge: collagen
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • Number of events 2 • Up to 30 days
|
20.7%
6/29 • Number of events 6 • Up to 30 days
|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24 • Number of events 4 • Up to 30 days
|
13.8%
4/29 • Number of events 4 • Up to 30 days
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Number of events 4 • Up to 30 days
|
10.3%
3/29 • Number of events 3 • Up to 30 days
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • Up to 30 days
|
6.9%
2/29 • Number of events 2 • Up to 30 days
|
|
Renal and urinary disorders
DYSURIA
|
8.3%
2/24 • Number of events 2 • Up to 30 days
|
0.00%
0/29 • Up to 30 days
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.3%
2/24 • Number of events 2 • Up to 30 days
|
3.4%
1/29 • Number of events 1 • Up to 30 days
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER