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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345787
• Other study ID #: BUP3801
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: April 11, 2008
• Start date: May 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2008
• Source: Mundipharma Pte Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Drug:
• Placebo
Corresponding placebo is applied for 12weeks
• Buprenorphine Transdermal System
Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks

Locations

Country	Name	City	State
Japan	Investigational Site	Adachi	Tokyo
Japan	Investigational Site	Annaka	Gunma
Japan	Investigational Site	Arakawa	Tokyo
Japan	Investigational Site	Chitose	Hokkaido
Japan	Investigational Site	Edogawa	Tokyo
Japan	Investigational Site	Fukui
Japan	Investigational Site	Hikone	Shiga
Japan	Investigational Site	Himi	Toyama
Japan	Investigational Site	Ichikawa	Chiba
Japan	Investigational Site	Isahaya	Nagasaki
Japan	Investigational Site	Joyo	Kyoto
Japan	Investigational Site	Kako	Hyogo
Japan	Investigational Site	Kasukabe	Saitama
Japan	Investigational Site	Kobe	Hyogo
Japan	Investigational Site	Koshigaya	Saitama
Japan	Investigational Site	Koto	Tokyo
Japan	Investigational Site	Kurobe	Toyama
Japan	Investigational Site	Matsudo	Chiba
Japan	Investigational Site	Nagareyama	Chiba
Japan	Investigational Site	Nagoya	Aichi
Japan	Investigational Site	Okazaki	Aichi
Japan	Investigational Site	Osaka
Japan	Investigational Site	Sapporo	Hokkaido
Japan	Investigational Site	Sendai	Miyagi
Japan	Investigational Site	Setagaya	Tokyo
Japan	Investigational Site	Suginami	Tokyo
Japan	Investigational Site	Takasaki	Gunma
Japan	Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to the development of inadequate analgesia		Up to 12weeks	No
Secondary	Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores		12weeks	No