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NCT01633944 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
A Phase 3 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
NCT01633944 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 752 participants.
The verdict
NCT01633944, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Interventions
- DRUG Placebo
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01633944
The ClinicalTrials.gov registry entry for NCT01633944 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 752 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01633944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01633944 about?
NCT01633944 is a clinical study titled "Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects". The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
What is the current status of trial NCT01633944?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2012-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01633944?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01633944?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
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