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NCT01141283 · ClinicalTrials.gov registry record · Phase 3

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

A Phase 3 study of Osteoarthritis, sponsored by Purdue Pharma.

Completed
Registry status
Phase 3
Development phase
290
Enrollment target
20
Study locations

NCT01141283 is a Phase 3 study of Osteoarthritis that has completed, run by Purdue Pharma. The registered enrollment target is 290 participants, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT01141283, a Phase 3 study of Osteoarthritis, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 3
Development phase
290 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Conditions Studied

Interventions

  • DRUG Buprenorphine transdermal patch

Study Locations (20)

Florida

  • Research Facility - Atlantis
  • Allergy, Asthma, Arthritis & Lung - Daytona Beach
  • University Clinical Research Deland - DeLand
  • Research Facility - Jupiter
  • Coastal Medical Research - Orange City
  • Research Facility - Plantation
  • Research Facility - West Palm Beach

Arizona

  • Vista Medical Research Inc. - Mesa
  • Arthrocare, Arthritis Care and Research - Phoenix
  • Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research - Phoenix
  • Arizona Research Center - Phoenix
  • Research Facility - Tucson

California

  • Advanced Pain Medicine - Bakersfield
  • Orange County Clinical Research - Cypress
  • San Diego Arthritis & Osteoporosis Medical Clinic - San Diego
  • Research Facility - San Diego
  • Research Facility - San Francisco

Colorado

  • Research Facility - Denver
  • Research Facility - Westminster

Connecticut

  • Research Facility - Bridgeport

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2003-04
Est. Completion 2004-07
Phase Phase 3

Sponsor

Purdue Pharma

54 total trials

What the Registry Record Tells You About NCT01141283

The ClinicalTrials.gov registry entry for NCT01141283 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (64% lower). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.

NCT01141283 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01141283 about?

NCT01141283 is a clinical study titled "Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase". The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

What is the current status of trial NCT01141283?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2003-04. Estimated completion is 2004-07.

What conditions does trial NCT01141283 study?

This clinical trial studies the following conditions: Osteoarthritis.

What interventions are being tested in trial NCT01141283?

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

Who is sponsoring clinical trial NCT01141283?

This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01141283 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.