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NCT Number: NCT00345787

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

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.

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Key information

Conditions

Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Drug

Corresponding placebo is applied for 12weeks

Buprenorphine Transdermal System

Drug

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

Primary outcomes

  1. The time to the development of inadequate analgesia

    Time frame: Up to 12weeks

Secondary outcomes

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

    Time frame: 12weeks

Sponsors and collaborators

Lead sponsor

Mundipharma K.K.

Industry

Registry information

Official study 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 Osteoarthritic Pain of the Hip or Knee

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 29, 2006
Registry last updated
Apr 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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