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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 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 150 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01928381
The ClinicalTrials.gov registry entry for NCT01928381 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01928381 reports 0 study locations.
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.
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