- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346047
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
April 11, 2008 updated by: Mundipharma K.K.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
Study Type
Interventional
Enrollment (Actual)
238
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
- Investigational Site
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Niigata, Japan
- Investigational Site
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Osaka, Japan
- Investigational Site
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Chiba
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Ichikawa, Chiba, Japan
- Investigational Site
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Matsudo, Chiba, Japan
- Investigational Site
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Noda, Chiba, Japan
- Investigational Site
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Fukuoka
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Asakura, Fukuoka, Japan
- Investigational Site
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Kasuya, Fukuoka, Japan
- Investigational Site
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Gunma
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Takasaki, Gunma, Japan
- Investigational Site
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Hokkaido
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Sapporo, Hokkaido, Japan
- Investigational Site
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Hyogo
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Kobe, Hyogo, Japan
- Investigational Site
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Ibaraki
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Yuki, Ibaraki, Japan
- Investigational Site
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Ishikawa
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Kanazawa, Ishikawa, Japan
- Investigational Site
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Komatsu, Ishikawa, Japan
- Investigational Site
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Iwate
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Hanamaki, Iwate, Japan
- Investigational Site
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Morioka, Iwate, Japan
- Investigational Site
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Kanagawa
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Yokohama, Kanagawa, Japan
- Investigational Site
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Miyagi
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Sendai, Miyagi, Japan
- Investigational Site
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Osaka
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Yao, Osaka, Japan
- Investigational Site
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Saitama
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Koshigaya, Saitama, Japan
- Investigational Site
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Tokorozawa, Saitama, Japan
- Investigational Site
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Shiga
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Hikone, Shiga, Japan
- Investigational Site
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Tokyo
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Adachi, Tokyo, Japan
- Investigational Site
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Arakawa, Tokyo, Japan
- Investigational Site
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Edogawa, Tokyo, Japan
- Investigational Site
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Itabashi, Tokyo, Japan
- Investigational Site
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Ota, Tokyo, Japan
- Investigational Site
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Suginami, Tokyo, Japan
- Investigational Site
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Toshima, Tokyo, Japan
- Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
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Placebo Comparator
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Corresponding placebo is applied for 12weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time to the development of inadequate analgesia.
Time Frame: Up to 12weeks
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Up to 12weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mutsukuni Kataoka, Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
June 27, 2006
First Submitted That Met QC Criteria
June 28, 2006
First Posted (Estimate)
June 29, 2006
Study Record Updates
Last Update Posted (Estimate)
April 15, 2008
Last Update Submitted That Met QC Criteria
April 11, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUP3802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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