Trial Outcomes & Findings for A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy (NCT NCT01201317)
NCT ID: NCT01201317
Last Updated: 2014-04-25
Results Overview
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
COMPLETED
PHASE2
134 participants
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
2014-04-25
Participant Flow
The first participant was enrolled on 20th September 2010 and the last participant completed on 6th June 2011. A total of 20 centres in United States (US) and Canada randomised 134 participants.
The study had an enrolment phase of up to 35 days (including wash-out and baseline periods), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.
Participant milestones
| Measure |
AZD2423 150 mg
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
tablets, 20 mg once daily in the morning
|
Placebo
tablets, once daily in the morning
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
41
|
|
Overall Study
COMPLETED
|
39
|
38
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
8
|
Reasons for withdrawal
| Measure |
AZD2423 150 mg
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
tablets, 20 mg once daily in the morning
|
Placebo
tablets, once daily in the morning
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
3
|
|
Overall Study
Adverse Event
|
2
|
2
|
2
|
|
Overall Study
Screen failure
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Study-specific withdrawal criteria
|
0
|
0
|
1
|
|
Overall Study
Painful Diabetic Neuropathy worsening
|
0
|
1
|
0
|
|
Overall Study
Decrease in renal function
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Safety, possible history of tuberculosis
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Baseline characteristics by cohort
| Measure |
AZD2423 150 mg
n=48 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=45 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=41 Participants
tablets, once daily in the morning
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
59.6 Years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
56.4 Years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
58 Years
STANDARD_DEVIATION 8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28Population: Intention-to-treat set (ITT)
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
Outcome measures
| Measure |
AZD2423 150 mg
n=46 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=42 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=39 Participants
tablets, once daily in the morning
|
|---|---|---|---|
|
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
|
-1.35 Scores on a scale
Standard Deviation 1.89
|
-1.50 Scores on a scale
Standard Deviation 1.77
|
-1.61 Scores on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28Population: Intention-to-treat set (ITT)
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.
Outcome measures
| Measure |
AZD2423 150 mg
n=46 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=42 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=39 Participants
tablets, once daily in the morning
|
|---|---|---|---|
|
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.
|
-1.57 Scores on a scale
Standard Deviation 1.96
|
-1.66 Scores on a scale
Standard Deviation 2.06
|
-1.80 Scores on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to Day 28Population: Intention-to-treat set (ITT)
Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)\*100. Responder= NRS Average Pain score reduction ≥30% (yes/no)
Outcome measures
| Measure |
AZD2423 150 mg
n=46 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=42 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=39 Participants
tablets, once daily in the morning
|
|---|---|---|---|
|
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
|
16 Participants
|
19 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to Day 28Population: Intention-to-treat set (ITT)
Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)\*100. Responder= NRS Average Pain score reduction ≥50% (yes/no)
Outcome measures
| Measure |
AZD2423 150 mg
n=46 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=42 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=39 Participants
tablets, once daily in the morning
|
|---|---|---|---|
|
Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
|
10 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29 (Visit 7)Population: Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data
Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.
Outcome measures
| Measure |
AZD2423 150 mg
n=35 Participants
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=30 Participants
tablets, 20 mg once daily in the morning
|
Placebo
n=33 Participants
tablets, once daily in the morning
|
|---|---|---|---|
|
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.
|
-14.63 Scores on a scale
Standard Deviation 22.77
|
-12.20 Scores on a scale
Standard Deviation 22.84
|
-7.82 Scores on a scale
Standard Deviation 17.02
|
Adverse Events
AZD2423 150 mg
AZD2423 20 mg
Placebo
Serious adverse events
| Measure |
AZD2423 150 mg
n=47 participants at risk
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=44 participants at risk
tablets, 20 mg once daily in the morning
|
Placebo
n=41 participants at risk
tablets, once daily in the morning
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
General disorders
Sudden cardiac death
|
0.00%
0/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
Other adverse events
| Measure |
AZD2423 150 mg
n=47 participants at risk
tablets, 150 mg once daily in the morning
|
AZD2423 20 mg
n=44 participants at risk
tablets, 20 mg once daily in the morning
|
Placebo
n=41 participants at risk
tablets, once daily in the morning
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
6.4%
3/47
Safety analysis set
|
0.00%
0/44
Safety analysis set
|
2.4%
1/41
Safety analysis set
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
2.4%
1/41
Safety analysis set
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
2.4%
1/41
Safety analysis set
|
|
General disorders
Pyrexia
|
4.3%
2/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/47
Safety analysis set
|
0.00%
0/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
2/47
Safety analysis set
|
0.00%
0/44
Safety analysis set
|
0.00%
0/41
Safety analysis set
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47
Safety analysis set
|
4.5%
2/44
Safety analysis set
|
7.3%
3/41
Safety analysis set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/47
Safety analysis set
|
2.3%
1/44
Safety analysis set
|
7.3%
3/41
Safety analysis set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47
Safety analysis set
|
0.00%
0/44
Safety analysis set
|
4.9%
2/41
Safety analysis set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No such publication or presentation may include any of AstraZeneca's Confidential Information without AstraZeneca's prior written approval. AZ should have 60 days for review and can extend time until submission up to 90 days.
- Publication restrictions are in place
Restriction type: OTHER