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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Buprenorphine Transdermal System
Sponsored by
Mundipharma K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Investigational Site
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  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

0

1

Arm Description

Outcomes

Primary Outcome Measures

The time to the development of inadequate analgesia.

Secondary Outcome Measures

Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores

Full Information

First Posted
June 27, 2006
Last Updated
April 11, 2008
Sponsor
Mundipharma K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT00346047
Brief Title
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mundipharma K.K.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Corresponding placebo is applied for 12weeks
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Transdermal System
Intervention Description
Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
Primary Outcome Measure Information:
Title
The time to the development of inadequate analgesia.
Time Frame
Up to 12weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mutsukuni Kataoka
Organizational Affiliation
Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site
City
Ichikawa
State/Province
Chiba
Country
Japan
Facility Name
Investigational Site
City
Matsudo
State/Province
Chiba
Country
Japan
Facility Name
Investigational Site
City
Noda
State/Province
Chiba
Country
Japan
Facility Name
Investigational Site
City
Asakura
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Kasuya
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Investigational Site
City
Yuki
State/Province
Ibaraki
Country
Japan
Facility Name
Investigational Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Investigational Site
City
Komatsu
State/Province
Ishikawa
Country
Japan
Facility Name
Investigational Site
City
Hanamaki
State/Province
Iwate
Country
Japan
Facility Name
Investigational Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Investigational Site
City
Yao
State/Province
Osaka
Country
Japan
Facility Name
Investigational Site
City
Koshigaya
State/Province
Saitama
Country
Japan
Facility Name
Investigational Site
City
Tokorozawa
State/Province
Saitama
Country
Japan
Facility Name
Investigational Site
City
Hikone
State/Province
Shiga
Country
Japan
Facility Name
Investigational Site
City
Adachi
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Edogawa
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Itabashi
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Ota
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Suginami
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Toshima
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Niigata
Country
Japan
Facility Name
Investigational Site
City
Osaka
Country
Japan

12. IPD Sharing Statement

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

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