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NCT01298765 · ClinicalTrials.gov registry record · Phase 3

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

A Phase 3 study, sponsored by BioDelivery Sciences International.

Completed
Registry status
Phase 3
Development phase
302
Enrollment target

NCT01298765: Completed Phase 3 study, sponsored by BioDelivery Sciences International.

NCT01298765 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01298765, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.

COMPLETED
Registry status
Phase 3
Development phase
302 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Primary Outcome

The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.

Interventions

  • DRUG BEMA Buprenorphine

Trial Details

FieldValue
Enrollment Target 302 participants
Start Date 2011-03
Est. Completion 2012-08
Phase Phase 3
BioDelivery Sciences International

17 total trials

What the finished NCT01298765 record still lists

NCT01298765 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 1 intervention - of which BEMA Buprenorphine is the first listed.

NCT01298765 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01298765 about?

NCT01298765 is a clinical study titled "Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain". The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

What is the current status of trial NCT01298765?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2011-03. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01298765?

The interventions under investigation include: BEMA Buprenorphine (DRUG).

Who is sponsoring clinical trial NCT01298765?

This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01298765's enrollment target sits among peer trials

302 1119th of 2000 higher than 880 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01298765, the US trial registry maintained by the National Library of Medicine. NCT01298765 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.