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NCT01256450 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

A Phase 3 study, sponsored by BioDelivery Sciences International.

Completed
Registry status
Phase 3
Development phase
334
Enrollment target

NCT01256450 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 334 participants.

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The verdict

NCT01256450, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.

COMPLETED
Registry status
Phase 3
Development phase
334 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

Interventions

  • DRUG Placebo
  • DRUG Buprenorphine

Trial Details

FieldValue
Enrollment Target 334 participants
Start Date 2010-11
Est. Completion 2011-07
Phase Phase 3

Sponsor

BioDelivery Sciences International

17 total trials

What the Registry Record Tells You About NCT01256450

The ClinicalTrials.gov registry entry for NCT01256450 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 334 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.

NCT01256450 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01256450 about?

NCT01256450 is a clinical study titled "Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain". The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

What is the current status of trial NCT01256450?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 334 participants. The study started on 2010-11. Estimated completion is 2011-07.

What interventions are being tested in trial NCT01256450?

The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).

Who is sponsoring clinical trial NCT01256450?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.