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NCT01928381 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT01928381: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01928381 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928381, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting training program in which a painful stimulus will be applied to the subject's hand, and the subjects will be asked to report how painful the stimulus is. Over the course of the pain training sessions, feedback will be provided to the subject about how accurately they are reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke pain. Those subjects who have adequate pain reporting ability will be asked to continue into Part 2 of the study in which 3 different blinded study drugs will be administered to each subject, in a crossover design to compare whether or not the study drugs improve pain associated with diabetic neuropathy.
Primary Outcome
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
Interventions
- DRUG Placebo
- DRUG AZD5213 + pregabalin
- DRUG pregabalin capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01928381 record still lists
NCT01928381 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01928381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928381 about?
NCT01928381 is a clinical study titled "Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability". This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting training program in which a painful stimulus will be applied to the subject's hand, and the subjects will be asked to report how painful the stimulus is. Over the course of the pain training sessions, feedback wil...
What is the current status of trial NCT01928381?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2013-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01928381?
The interventions under investigation include: Placebo (DRUG), AZD5213 + pregabalin (DRUG), pregabalin capsules (DRUG).
Who is sponsoring clinical trial NCT01928381?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928381's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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