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Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345787
First Posted: June 29, 2006
Last Update Posted: April 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mundipharma Pte Ltd.
  Purpose
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

Condition Intervention Phase
Pain Osteoarthritis Drug: Placebo Drug: Buprenorphine Transdermal System Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • The time to the development of inadequate analgesia [ Time Frame: Up to 12weeks ]

Secondary Outcome Measures:
  • Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores [ Time Frame: 12weeks ]

Enrollment: 262
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 Drug: Placebo
Corresponding placebo is applied for 12weeks
Experimental: 1 Drug: Buprenorphine Transdermal System
Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks

Detailed Description:
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ages 40 years or older.
  • Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

Exclusion Criteria:

  • Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345787


Locations
Japan
Investigational Site
Nagoya, Aichi, Japan
Investigational Site
Okazaki, Aichi, Japan
Investigational Site
Ichikawa, Chiba, Japan
Investigational Site
Matsudo, Chiba, Japan
Investigational Site
Nagareyama, Chiba, Japan
Investigational Site
Annaka, Gunma, Japan
Investigational Site
Takasaki, Gunma, Japan
Investigational Site
Chitose, Hokkaido, Japan
Investigational Site
Sapporo, Hokkaido, Japan
Investigational Site
Kako, Hyogo, Japan
Investigational Site
Kobe, Hyogo, Japan
Investigational Site
Yokohama, Kanagawa, Japan
Investigational Site
Joyo, Kyoto, Japan
Investigational Site
Sendai, Miyagi, Japan
Investigational Site
Isahaya, Nagasaki, Japan
Investigational Site
Kasukabe, Saitama, Japan
Investigational Site
Koshigaya, Saitama, Japan
Investigational Site
Hikone, Shiga, Japan
Investigational Site
Adachi, Tokyo, Japan
Investigational Site
Arakawa, Tokyo, Japan
Investigational Site
Edogawa, Tokyo, Japan
Investigational Site
Koto, Tokyo, Japan
Investigational Site
Setagaya, Tokyo, Japan
Investigational Site
Suginami, Tokyo, Japan
Investigational Site
Himi, Toyama, Japan
Investigational Site
Kurobe, Toyama, Japan
Investigational Site
Fukui, Japan
Investigational Site
Osaka, Japan
Sponsors and Collaborators
Mundipharma K.K.
Investigators
Study Chair: Mutsukuni Kataoka Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
  More Information

Responsible Party: Mutsukuni Kataoka, Mundipharma K.K.
ClinicalTrials.gov Identifier: NCT00345787     History of Changes
Other Study ID Numbers: BUP3801
First Submitted: June 27, 2006
First Posted: June 29, 2006
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Mundipharma Pte Ltd.:
Osteoarthritic Pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists