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

NCT ID: NCT00346047

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Corresponding placebo is applied for 12weeks

1

Group Type EXPERIMENTAL

Buprenorphine Transdermal System

Intervention Type DRUG

Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks

Interventions

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Placebo

Corresponding placebo is applied for 12weeks

Intervention Type DRUG

Buprenorphine Transdermal System

Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Mundipharma K.K.

Principal Investigators

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Mutsukuni Kataoka

Role: STUDY_CHAIR

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

Locations

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Investigational Site

Ichikawa, Chiba, Japan

Site Status

Investigational Site

Matsudo, Chiba, Japan

Site Status

Investigational Site

Noda, Chiba, Japan

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Investigational Site

Asakura, Fukuoka, Japan

Site Status

Investigational Site

Fukuoka, Fukuoka, Japan

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Investigational Site

Wakasugi, Fukuoka, Japan

Site Status

Investigational Site

Takasaki, Gunma, Japan

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Investigational Site

Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

Site Status

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Yūki, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Komatsu, Ishikawa-ken, Japan

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Investigational Site

Hanamaki, Iwate, Japan

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Morioka, Iwate, Japan

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Yokohama, Kanagawa, Japan

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Sendai, Miyagi, Japan

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Niigata, Niigata, Japan

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Osaka, Osaka, Japan

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Yao, Osaka, Japan

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Koshigaya, Saitama, Japan

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Tokorozawa, Saitama, Japan

Site Status

Investigational Site

Hikone, Shiga, Japan

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Investigational Site

Adachi City, Tokyo, Japan

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Investigational Site

Arakawa City, Tokyo, Japan

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Investigational Site

Edogawa City, Tokyo, Japan

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Investigational Site

Ōta-ku, Tokyo, Japan

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Investigational Site

Suginami, Tokyo, Japan

Site Status

Investigational Site

tabashi City, Tokyo, Japan

Site Status

Investigational Site

Toshima City, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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BUP3802

Identifier Type: -

Identifier Source: org_study_id