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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346047

Enrollment

238

Registered

2006-06-29

Start date

2006-05-31

Completion date

2007-07-31

Last updated

2008-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

DRUGPlacebo

Corresponding placebo is applied for 12weeks

DRUGBuprenorphine Transdermal System

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
The time to the development of inadequate analgesia.	Up to 12weeks

Secondary

Measure	Time frame
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores	Up to 12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026