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

This study has been completed.
Sponsor:
Information provided by:
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT00346047
First received: June 27, 2006
Last updated: April 11, 2008
Last verified: April 2008
  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 Pte Ltd.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014