Clinical Trials Logo
  1. Home
  2. Chronic Low Back Pain
  3. NCT01364922

Phase 2 Chronic Low Back Pain Study

Chronic Low Back Pain Clinical Trial

Official title:
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain

Clinical Trial Summary

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Clinical Trial Description

This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01364922
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 2
Start date June 2011
Completion date October 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT03243084 - Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Completed NCT03162952 - RAND Center of Excellence for the Study of Appropriateness of Care in CAM
Completed NCT03240146 - Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain N/A
Completed NCT05282589 - Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients N/A
Completed NCT03637998 - Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain N/A
Recruiting NCT02289170 - Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) N/A
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT02231554 - Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial N/A
Recruiting NCT02063503 - Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up N/A
Completed NCT01177280 - Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes N/A
Completed NCT01177254 - Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions N/A
Completed NCT01490905 - A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain Phase 4
Completed NCT01177241 - Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids N/A
Completed NCT00984815 - Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Phase 3
Completed NCT00767806 - A Study for Patient With Chronic Low Back Pain Phase 3
Completed NCT00761150 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00763321 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3