Trial Outcomes & Findings for A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia.. (NCT NCT01200524)
NCT ID: NCT01200524
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) scale 0-10. 0= No pain, 10= Worst pain imaginable.
COMPLETED
PHASE2
133 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 6th October 2010 and the last participant completed on 3rd April 2012. A total of 36 centres in France, Denmark, Poland, Russia, UK, Sweden and Bulgaria randomised 133 participants.
The study had an enrolment phase of up to 30 days (including wash-out period), 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
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
48
|
44
|
|
Overall Study
COMPLETED
|
39
|
47
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
AZD2423, 150 mg
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Non availability of study nurse
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Baseline characteristics by cohort
| Measure |
AZD2423, 150 mg
n=41 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=48 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=44 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.9 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
55.1 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28Population: mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28
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) scale 0-10. 0= No pain, 10= Worst pain imaginable.
Outcome measures
| Measure |
AZD2423, 150 mg
n=41 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=47 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=43 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
|
-1.53 Scores on a scale
Standard Deviation 1.67
|
-1.54 Scores on a scale
Standard Deviation 1.50
|
-1.44 Scores on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28Population: mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28
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=41 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=47 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=43 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
|
-1.8 Scores on a scale
Standard Deviation 2.09
|
-1.29 Scores on a scale
Standard Deviation 1.5
|
-1.4 Scores on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to Day 28Population: mITT analysis set
LOCF- Last Observation Carried Forward. 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=41 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=48 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=44 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
|
17 Participants
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline (mean of Day -5 to Day -1) to Day 28Population: mITT analysis set
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=41 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=48 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=44 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
|
9 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29 (Visit 7)Population: mITT analysis set including only those that had adequate NPSI data at baseline and Day 29
LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.
Outcome measures
| Measure |
AZD2423, 150 mg
n=26 Participants
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=34 Participants
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=30 Participants
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
|
-16.58 Scores on a scale
Standard Deviation 22.40
|
-8.82 Scores on a scale
Standard Deviation 18.11
|
-9.8 Scores on a scale
Standard Deviation 15.44
|
Adverse Events
AZD2423, 150 mg
AZD2423, 20mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD2423, 150 mg
n=41 participants at risk
AZD2423 : 3x50 mg tablet once daily in the morning
|
AZD2423, 20mg
n=48 participants at risk
AZD2423 : 1x20 mg tablet once daily in the morning
|
Placebo
n=44 participants at risk
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.8%
4/41
|
6.2%
3/48
|
4.5%
2/44
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41
|
2.1%
1/48
|
2.3%
1/44
|
|
General disorders
Asthenia
|
0.00%
0/41
|
6.2%
3/48
|
0.00%
0/44
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41
|
10.4%
5/48
|
9.1%
4/44
|
|
Nervous system disorders
Headache
|
14.6%
6/41
|
8.3%
4/48
|
6.8%
3/44
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The agreement restricts the PI's rights to discuss or publish trial results after the trial is completed. No publication or presentation may include any of AZ's Confidential Information without AZ'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