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COMPLETED Phase 3

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

NCT00315848 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Conditions Studied

Interventions

  • DRUG Buprenorphine transdermal delivery system

Study Locations (10)

Arizona

  • Arizona Research and Education — Phoenix
  • Phoenix Center for Clinical Research — Phoenix

Florida

  • Gainesville Clinical Research Center — Gainesville
  • Park Place Therapeutic Center — Plantation

Texas

  • Metroplex Clinical Research Center — Dallas
  • Arthritis Diagnostic and Treatment Center — San Antonio

Alabama

  • Rheumatology Associates of North Alabama — Huntsville

Colorado

  • Western Integrated Pain Treatment Centers — Westminster

Indiana

  • MediSphere Medical Research Center, L.L.C. — Evansville

New York

  • Stratton VA Medical Center — Albany

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 1996-11
Est. Completion 1999-12
Phase Phase 3

Sponsor

Purdue Pharma

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00315848

The ClinicalTrials.gov registry entry for NCT00315848 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which Buprenorphine transdermal delivery system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00315848 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Arizona, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00315848 about?

NCT00315848 is a clinical study titled "The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opi...

What is the current status of trial NCT00315848?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 1996-11. Estimated completion is 1999-12.

What conditions does trial NCT00315848 study?

This clinical trial studies the following conditions: Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00315848?

The interventions under investigation include: Buprenorphine transdermal delivery system (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00315848?

This trial is sponsored by Purdue Pharma, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00315848 being conducted?

This trial has 10 study locations across Alabama, Arizona, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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