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

Mundipharma

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: Buprenorphine Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346047

BUP3802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 2 patient groups, including a placebo group

0

Placebo Comparator group

Treatment:

Drug: Placebo

1

Experimental group

Treatment:

Drug: Buprenorphine Transdermal System