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NCT00315887 · ClinicalTrials.gov registry record · Phase 3

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

A Phase 3 study, sponsored by Purdue Pharma.

Completed
Registry status
Phase 3
Development phase
250
Enrollment target

NCT00315887 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 250 participants.

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The verdict

NCT00315887, a Phase 3 study, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 3
Development phase
250 participants
Enrollment target

Study Summary

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

Interventions

  • DRUG Buprenorphine transdermal delivery system

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 1999-04
Est. Completion 1999-10
Phase Phase 3

Sponsor

Purdue Pharma

54 total trials

What the Registry Record Tells You About NCT00315887

The ClinicalTrials.gov registry entry for NCT00315887 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 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 1 intervention - of which Buprenorphine transdermal delivery system is the first listed.

NCT00315887 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00315887 about?

NCT00315887 is a clinical study titled "The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.". The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during...

What is the current status of trial NCT00315887?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 1999-04. Estimated completion is 1999-10.

What interventions are being tested in trial NCT00315887?

The interventions under investigation include: Buprenorphine transdermal delivery system (DRUG).

Who is sponsoring clinical trial NCT00315887?

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.