A Phase 2 interventional study of AZD2423 and AZD2423 in Nerve Pain, sponsored by AstraZeneca. Completed at 25 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-25.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 133 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Drug: AZD2423
Drug: AZD2423
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Drug: Placebo
20 mg tablet
50 mg tablet
Placebo
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
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.
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
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.
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
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)
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
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)
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
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.
Time frame: Baseline (Day 1) to Day 29 (Visit 7)
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.
| Milestone | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Started | 41 | 48 | 44 |
| Completed | 39 | 47 | 40 |
| Not completed | 2 | 1 | 4 |
| Withdrew: Withdrawal by subject | 1 | 1 | 3 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Non availability of study nurse | 0 | 0 | 1 |
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.
| Scores on a scale | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | -1.53 ± 1.67 | -1.54 ± 1.50 | -1.44 ± 1.59 |
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.
| Scores on a scale | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | -1.8 ± 2.09 | -1.29 ± 1.5 | -1.4 ± 1.66 |
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)
| Participants | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | 17 | 15 | 17 |
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)
| Participants | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | 9 | 8 | 9 |
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.
| Scores on a scale | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | -16.58 ± 22.40 | -8.82 ± 18.11 | -9.8 ± 15.44 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD2423, 150 mg | — | 0/41 (0%) | 14/41 (34.1%) |
| AZD2423, 20mg | — | 0/48 (0%) | 14/48 (29.2%) |
| Placebo | — | 0/44 (0%) | 10/44 (22.7%) |
| Event | AZD2423, 150 mg | AZD2423, 20mg | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 6/41 | 4/48 | 3/44 |
| NasopharyngitisInfections and infestations | 2/41 | 5/48 | 4/44 |
| NauseaGastrointestinal disorders | 4/41 | 3/48 | 2/44 |
| DiarrhoeaGastrointestinal disorders | 3/41 | 1/48 | 1/44 |
| AstheniaGeneral disorders | 0/41 | 3/48 | 0/44 |
| Age, Continuous(Years) | AZD2423, 150 mg | AZD2423, 20mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 50.9 ± 10.9 | 53.1 ± 10.9 | 55.1 ± 10.9 | 53.1 ± 10.9 |
| Sex: Female, Male(Participants) | AZD2423, 150 mg | AZD2423, 20mg | Placebo | Total |
|---|---|---|---|---|
| Female | 17 | 26 | 19 | 62 |
| Male | 24 | 22 | 25 | 71 |
| Race/Ethnicity, Customized(Participants) | AZD2423, 150 mg | AZD2423, 20mg | Placebo | Total |
|---|---|---|---|---|
| White | 41 | 47 | 44 | 132 |
| Black or African American | 0 | 1 | 0 | 1 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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