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

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.
ClinicalTrials.gov Identifier: NCT00345787
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : April 15, 2008
Sponsor:
Information provided by:
Mundipharma Pte Ltd.

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 29, 2006
Last Update Posted Date April 15, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
The time to the development of inadequate analgesia [ Time Frame: Up to 12weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
The time to the development of inadequate analgesia.
Change History Complete list of historical versions of study NCT00345787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores [ Time Frame: 12weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Osteoarthritis
Intervention  ICMJE
  • Drug: Placebo
    Corresponding placebo is applied for 12weeks
  • Drug: Buprenorphine Transdermal System
    Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks
Study Arms  ICMJE
  • Placebo Comparator: 0
    Intervention: Drug: Placebo
  • Experimental: 1
    Intervention: Drug: Buprenorphine Transdermal System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2008)
262
Original Enrollment  ICMJE
 (submitted: June 28, 2006)
124
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00345787
Other Study ID Numbers  ICMJE BUP3801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mutsukuni Kataoka, Mundipharma K.K.
Study Sponsor  ICMJE Mundipharma K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mutsukuni Kataoka Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
PRS Account Mundipharma Pte Ltd.
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP