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

Low Back 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 Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346047
• Other study ID #: BUP3802
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: April 11, 2008
• Start date: May 2006
• Est. completion date: July 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 low back pain.

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 low back pain 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: 238
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Males or females age 20 years or older.

• Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.

Exclusion Criteria:

• Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis 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

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Japan	Investigational Site	Adachi	Tokyo
Japan	Investigational Site	Arakawa	Tokyo
Japan	Investigational Site	Asakura	Fukuoka
Japan	Investigational Site	Edogawa	Tokyo
Japan	Investigational Site	Fukuoka
Japan	Investigational Site	Hanamaki	Iwate
Japan	Investigational Site	Hikone	Shiga
Japan	Investigational Site	Ichikawa	Chiba
Japan	Investigational Site	Itabashi	Tokyo
Japan	Investigational Site	Kanazawa	Ishikawa
Japan	Investigational Site	Kasuya	Fukuoka
Japan	Investigational Site	Kobe	Hyogo
Japan	Investigational Site	Komatsu	Ishikawa
Japan	Investigational Site	Koshigaya	Saitama
Japan	Investigational Site	Matsudo	Chiba
Japan	Investigational Site	Morioka	Iwate
Japan	Investigational Site	Niigata
Japan	Investigational Site	Noda	Chiba
Japan	Investigational Site	Osaka
Japan	Investigational Site	Ota	Tokyo
Japan	Investigational Site	Sapporo	Hokkaido
Japan	Investigational Site	Sendai	Miyagi
Japan	Investigational Site	Suginami	Tokyo
Japan	Investigational Site	Takasaki	Gunma
Japan	Investigational Site	Tokorozawa	Saitama
Japan	Investigational Site	Toshima	Tokyo
Japan	Investigational Site	Yao	Osaka
Japan	Investigational Site	Yokohama	Kanagawa
Japan	Investigational Site	Yuki	Ibaraki

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		Up to 12 weeks	No