Trial · NCT01201317
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
NCT01201317, Phase 2, Completed, AstraZeneca; results first posted 2013-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy. Trials, record NCT01201317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01201317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
- NCT number
- NCT01201317
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Neuropathic Pain
- Interventions
- AZD2423, AZD2423, Placebo
- First posted
- 2010-09-14
- Last updated
- 2014-04-25
- Results first posted
- 2013-09-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 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) 0-10; 0=No pain, 10=Worst pain imaginable. |
| Secondary | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 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. |
| Secondary | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to 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 ≥30% (yes/no) |
| Secondary | Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to 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) |
| Secondary | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score. | Baseline (Day 1) to Day 29 (Visit 7) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | Intention-to-treat set (ITT) | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | Intention-to-treat set (ITT) | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to Day 28 | Intention-to-treat set (ITT) | Participants | NUMBER |
| SECONDARY | Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to Day 28 | Intention-to-treat set (ITT) | Participants | NUMBER |
| SECONDARY | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score. | Baseline (Day 1) to Day 29 (Visit 7) | Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | AZD2423 150 mg | -1.35 | Standard Deviation 1.89 | Scores on a scale | |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | AZD2423 20 mg | -1.50 | Standard Deviation 1.77 | Scores on a scale | |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Placebo | -1.61 | Standard Deviation 2.26 | Scores on a scale | |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | AZD2423 150 mg | -1.57 | Standard Deviation 1.96 | Scores on a scale | |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | AZD2423 20 mg | -1.66 | Standard Deviation 2.06 | Scores on a scale | |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | Placebo | -1.80 | Standard Deviation 2.48 | Scores on a scale | |
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | AZD2423 150 mg | 16 | Participants | ||
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | AZD2423 20 mg | 19 | Participants | ||
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Placebo | 15 | Participants | ||
| Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | AZD2423 150 mg | 10 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD2423 150 mg | 48 | |
| Overall Study | STARTED | AZD2423 20 mg | 45 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | AZD2423 150 mg | 39 | |
| Overall Study | COMPLETED | AZD2423 20 mg | 38 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | AZD2423 150 mg | 9 | |
| Overall Study | NOT COMPLETED | AZD2423 20 mg | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | AZD2423 150 mg | 3 | 47 | |
| other | Headache | Nervous system disorders | AZD2423 20 mg | 0 | 44 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 41 | |
| other | Dizziness | Nervous system disorders | AZD2423 150 mg | 2 | 47 | |
| other | Dizziness | Nervous system disorders | AZD2423 20 mg | 1 | 44 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 41 | |
| other | Nausea | Gastrointestinal disorders | AZD2423 150 mg | 2 | 47 | |
| other | Nausea | Gastrointestinal disorders | AZD2423 20 mg | 1 | 44 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 41 | |
| other | Pyrexia | General disorders | AZD2423 150 mg | 2 | 47 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD2423 150 mg | ||
| Total, all-cause mortality | AZD2423 20 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AZD2423 150 mg | 14 | 47 |
| Total, other adverse events | AZD2423 20 mg | 6 | 44 |
| Total, other adverse events | Placebo | 11 | 41 |
| Total, serious adverse events | AZD2423 150 mg | 0 | 47 |
| Total, serious adverse events | AZD2423 20 mg | 3 | 44 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01201317
GET https://conductscience.org/api/trials/v1/NCT01201317/events?page=2