Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain - Full Text View

Sponsored by:	Mundipharma K.K.
Information provided by:	Mundipharma K.K.
ClinicalTrials.gov Identifier:	NCT00346047

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 III

MedlinePlus related topics: Back Pain

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Mundipharma K.K.:

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
0: Placebo Comparator	Drug: Placebo Corresponding placebo is applied for 12weeks
1: Experimental	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

Show 29 Study Locations

Sponsors and Collaborators

Mundipharma K.K.

Investigators

Study Chair:

Mutsukuni Kataoka

Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.

More Information

Responsible Party:	Mundipharma K.K. ( Mutsukuni Kataoka )
Study ID Numbers:	BUP3802
Study First Received:	June 27, 2006
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00346047
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Signs and Symptoms
Buprenorphine
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009