Clinical Trials Logo
  1. Home
  2. Back Pain Lower Back Chronic
  3. NCT01081912

Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

Back Pain Lower Back Chronic Clinical Trial

Official title:
A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

Clinical Trial Description

A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01081912
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date March 2010
Completion date October 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT01914666 - An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Completed NCT01761617 - Yoga Dosing Study for Chronic Low Back Pain N/A
Completed NCT03338192 - Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Active, not recruiting NCT03106740 - Evaluating the Role of Neuroinflammation in Low Back Pain Phase 2
Completed NCT02960269 - Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing N/A
Completed NCT04203888 - Personalized Trial for Chronic Lower Back Pain N/A
Not yet recruiting NCT05704751 - EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Completed NCT06351774 - Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain N/A
Terminated NCT01865539 - Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain N/A
Completed NCT01855919 - A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Enrolling by invitation NCT05386212 - The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
Completed NCT03299192 - Tai Chi for Chronic Low Back Pain in Older Adults N/A
Completed NCT04468074 - Virtual Reality Treatment for Adults With Chronic Back Pain N/A
Completed NCT01343927 - Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations N/A
Completed NCT01329861 - Internet-based Cognitive Behavioural Treatment for Chronic Back Pain N/A
Terminated NCT01125917 - Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015 Phase 3
Enrolling by invitation NCT05413070 - Quality Improvement re: Choosing Wisely Back Pain Measures
Recruiting NCT04893720 - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Recruiting NCT05953155 - YOga for Patients With Chronic BACK Pain and Poor PROgnosis N/A
Not yet recruiting NCT05297513 - Efficacy of ActiveMatrix on Spinal SSI Rate Phase 4