MedDataX Logo

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

NCT ID: NCT00345787

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoarthritic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 20mg/patch is applied for 12weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Corresponding placebo is applied for 12weeks

Intervention Type DRUG

Buprenorphine Transdermal System

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males or females ages 40 years or older.
* Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

Exclusion Criteria

* Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mundipharma K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mundipharma K.K.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mutsukuni Kataoka

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Investigational Site

Okazaki, Aichi-ken, Japan

Site Status

Investigational Site

Ichikawa, Chiba, Japan

Site Status

Investigational Site

Matsudo, Chiba, Japan

Site Status

Investigational Site

Nagareyama, Chiba, Japan

Site Status

Investigational Site

Fukui-shi, Fukui, Japan

Site Status

Investigational Site

Annaka, Gunma, Japan

Site Status

Investigational Site

Takasaki, Gunma, Japan

Site Status

Investigational Site

Chitose, Hokkaido, Japan

Site Status

Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Investigational Site

Kako, Hyōgo, Japan

Site Status

Investigational Site

Kobe, Hyōgo, Japan

Site Status

Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Investigational Site

Jōyō, Kyoto, Japan

Site Status

Investigational Site

Sendai, Miyagi, Japan

Site Status

Investigational Site

Isahaya, Nagasaki, Japan

Site Status

Investigational Site

Osaka, Osaka, Japan

Site Status

Investigational Site

Kasukabe, Saitama, Japan

Site Status

Investigational Site

Koshigaya, Saitama, Japan

Site Status

Investigational Site

Hikone, Shiga, Japan

Site Status

Investigational Site

Adachi City, Tokyo, Japan

Site Status

Investigational Site

Arakawa City, Tokyo, Japan

Site Status

Investigational Site

Edogawa City, Tokyo, Japan

Site Status

Investigational Site

Koto, Tokyo, Japan

Site Status

Investigational Site

Setagaya City, Tokyo, Japan

Site Status

Investigational Site

Suginami, Tokyo, Japan

Site Status

Investigational Site

Himi, Toyama, Japan

Site Status

Investigational Site

Kurobe-shi, Toyama, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BUP3801

Identifier Type: -

Identifier Source: org_study_id