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Completed

NCT Number: NCT00346047

Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back 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 low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Ichikawa, Chiba, 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 low back pain 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 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).

Treatment and study plan

Placebo

Drug

Corresponding placebo is applied for 12weeks

Buprenorphine Transdermal System

Drug

Buprenorphine Transdermal System 5, 10 or 20 mg/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: Up to 12 weeks

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 Low Back Pain

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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