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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00312195

Public ClinicalTrials.gov record NCT00312195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 3:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00312195
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Purdue Pharma LP
Industry
Enrollment
267 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2001 (Type not available)
Primary completion
Jul 2001 (Actual)
Completion
Jul 2001 (Actual)
Last update posted
Sep 10, 2012

2001

United States locations

U.S. sites
21
U.S. states
12
U.S. cities
20
Facility City State ZIP Site status
Hawthorne and York Phoenix Arizona 85008 —
Arizona Research Center Inc Phoenix Arizona 85023 —
Clinical Research Consultants Inc Trumbull Connecticut 06611 —
Tampa Bay Medical Research Inc Clearwater Florida 33761 —
Clinical Research of South Florida Coral Gables Florida 33134 —
University Clinical Research Deland DeLand Florida 32702 —
University Clinical Research Inc, Pembroke Pines Florida 33024 —
Gold Coast Research LLC Plantation Florida 33324 —
Gold Coast Research LLC Tamarac Florida 33321 —
Family Medicine Associates Evansville Indiana 47712 —
Pain Management and Rehabilitation Terre Haute Indiana 47802 —
Southeastern Center for Headache and Pain Crestview Heights Kentucky 41017 —
Westside Family Medical Center PC Kalamazoo Michigan 49009 —
The Arthritis Clinic Charlotte North Carolina 28211 —
Cornerstone Research Care High Point North Carolina 27262 —
ALL-TRIALS Clinical Research LLC Winston-Salem North Carolina 27103 —
Private Practice Chardon Ohio 44024 —
Summit Research Solutions Memphis Tennessee 38119 —
Radiant Research Austin Texas 78758 —
Wasatch Clinical Research Salt Lake City Utah 84107 —
Clinical Research Management New Berlin Wisconsin 53151 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00312195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2012 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00312195 live on ClinicalTrials.gov.

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