Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
This study has been completed.
Sponsor:
Mundipharma K.K.
Information provided by:
Mundipharma
ClinicalTrials.gov Identifier:
NCT00346047
First received: June 27, 2006
Last updated: April 11, 2008
Last verified: April 2008
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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 low back pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Placebo Drug: Buprenorphine Transdermal System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Low Back Pain |
Resource links provided by NLM:
Further study details as provided by Mundipharma:
Primary Outcome Measures:
- The time to the development of inadequate analgesia. [ Time Frame: Up to 12weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 238 |
| Study Start Date: | May 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 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 20 mg/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 low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346047
Locations
| Japan | |
| Investigational Site | |
| Ichikawa, Chiba, Japan | |
| Investigational Site | |
| Matsudo, Chiba, Japan | |
| Investigational Site | |
| Noda, Chiba, Japan | |
| Investigational Site | |
| Asakura, Fukuoka, Japan | |
| Investigational Site | |
| Kasuya, Fukuoka, Japan | |
| Investigational Site | |
| Takasaki, Gunma, Japan | |
| Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| Investigational Site | |
| Kobe, Hyogo, Japan | |
| Investigational Site | |
| Yuki, Ibaraki, Japan | |
| Investigational Site | |
| Kanazawa, Ishikawa, Japan | |
| Investigational Site | |
| Komatsu, Ishikawa, Japan | |
| Investigational Site | |
| Hanamaki, Iwate, Japan | |
| Investigational Site | |
| Morioka, Iwate, Japan | |
| Investigational Site | |
| Yokohama, Kanagawa, Japan | |
| Investigational Site | |
| Sendai, Miyagi, Japan | |
| Investigational Site | |
| Yao, Osaka, Japan | |
| Investigational Site | |
| Koshigaya, Saitama, Japan | |
| Investigational Site | |
| Tokorozawa, Saitama, Japan | |
| Investigational Site | |
| Hikone, Shiga, Japan | |
| Investigational Site | |
| Adachi, Tokyo, Japan | |
| Investigational Site | |
| Arakawa, Tokyo, Japan | |
| Investigational Site | |
| Edogawa, Tokyo, Japan | |
| Investigational Site | |
| Itabashi, Tokyo, Japan | |
| Investigational Site | |
| Ota, Tokyo, Japan | |
| Investigational Site | |
| Suginami, Tokyo, Japan | |
| Investigational Site | |
| Toshima, Tokyo, Japan | |
| Investigational Site | |
| Fukuoka, Japan | |
| Investigational Site | |
| Niigata, 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
No publications provided
| Responsible Party: | Mutsukuni Kataoka, Mundipharma K.K. |
| ClinicalTrials.gov Identifier: | NCT00346047 History of Changes |
| Other Study ID Numbers: | BUP3802 |
| Study First Received: | June 27, 2006 |
| Last Updated: | April 11, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Buprenorphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013