NCT02436824

A Study of a Topical Patch (AB001) in Patients With Chronic Low Back Pain

A Phase II, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Determine the Safety and Efficacy of a Topical Patch (AB001) Following Daily Administration for 2 Weeks in Patients With Chronic Low Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to examine the safety, tolerability, and efficacy of repeated topical administration of AB001 topical patches for the treatment of chronic low back pain.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group study of the safety and efficacy of AB001 topical patches in patients with chronic low back pain. Subjects meeting inclusion criteria are randomized in a 1:1 ratio to receive AB001 patches or placebo patches. Two AB001 or placebo patches will be given topically once daily for 14 days. The primary end point is the change of low back pain intensity rated on a visual analog scale (VAS) scale on Day 15, the secondary end points include the subject global assessment (SGA) of low back pain, the subject global perceived effect (GPE) of study medication, the Roland-Morris Disability Questionnaire (RMDQ), and the pain assessment from subject diary (Days 1 - 3 only). Subjects' safety will be monitored throughout the study, including the adverse event (AE) incidence and severity, laboratory test results (hematology and clinical chemistry), vital signs, and physical examination.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	AB001 patch	Two AB001 patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.
OTHER	Placebo patch	Two placebo patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-05-07
• Last updated: 2016-08-30

Locations

9 sites across 1 country: United States