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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346047
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : April 15, 2008
Information provided by:
Mundipharma Pte Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Placebo Drug: Buprenorphine Transdermal System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The time to the development of inadequate analgesia. [ Time Frame: Up to 12weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores [ Time Frame: Up to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346047

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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
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Takasaki, Gunma, Japan
Investigational Site
Sapporo, Hokkaido, Japan
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Kobe, Hyogo, Japan
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Yuki, Ibaraki, Japan
Investigational Site
Kanazawa, Ishikawa, Japan
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Komatsu, Ishikawa, Japan
Investigational Site
Hanamaki, Iwate, Japan
Investigational Site
Morioka, Iwate, Japan
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Yokohama, Kanagawa, Japan
Investigational Site
Sendai, Miyagi, Japan
Investigational Site
Yao, Osaka, Japan
Investigational Site
Koshigaya, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Hikone, Shiga, Japan
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Adachi, Tokyo, Japan
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Arakawa, Tokyo, Japan
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Edogawa, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Ota, Tokyo, Japan
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Suginami, Tokyo, Japan
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Toshima, Tokyo, Japan
Investigational Site
Fukuoka, Japan
Investigational Site
Niigata, Japan
Investigational Site
Osaka, Japan
Sponsors and Collaborators
Mundipharma K.K.
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Study Chair: Mutsukuni Kataoka Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.

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Responsible Party: Mutsukuni Kataoka, Mundipharma K.K. Identifier: NCT00346047     History of Changes
Other Study ID Numbers: BUP3802
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists