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NCT00312195 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

A Phase 3 study, sponsored by Purdue Pharma.

Completed
Registry status
Phase 3
Development phase
267
Enrollment target

NCT00312195 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 267 participants.

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The verdict

NCT00312195, a Phase 3 study, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 3
Development phase
267 participants
Enrollment target

Study Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Interventions

  • DRUG Buprenorphine transdermal patch
  • DRUG Placebo to match BTDS

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2001-03
Est. Completion 2001-07
Phase Phase 3

Sponsor

Purdue Pharma

54 total trials

What the Registry Record Tells You About NCT00312195

The ClinicalTrials.gov registry entry for NCT00312195 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Buprenorphine transdermal patch is the first listed.

NCT00312195 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00312195 about?

NCT00312195 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind tre...

What is the current status of trial NCT00312195?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2001-03. Estimated completion is 2001-07.

What interventions are being tested in trial NCT00312195?

The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Placebo to match BTDS (DRUG).

Who is sponsoring clinical trial NCT00312195?

This trial is sponsored by Purdue Pharma, which has 54 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.