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A Study of Pain Relief in Low Back Pain

CompletedPhase 3NCT00325949
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain

Study details

Official title
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (VicodinĀ® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
Interventions
  • Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)
  • Drug: hydrocodone/acetaminophen extended release (Vicodin CR)
  • Drug: placebo
Sponsor
Abbott
Start date
2006-05
Primary completion
2007-05
Sex
All
Age range
from 21 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
63

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Males and females, ages 21-75 years * If female, must be of non-child bearing potential or practicing birth control * Has a history of chronic low back pain for at least 6 months * Requires medication for the management of the chronic low back pain * Has sufficient pain to justify the use of around-the-clock opioids Exclusion Criteria: * Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study * Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen * Cannot discontinue pain medications, even for the short time prior to the study start * Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery * Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract * Has a history of malnutrition or starvation * Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day * Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder * Is a pregnant or breastfeeding woman * Is incapacitated, bedridden, or confined to a wheelchair * Has initiated any new therapy or medication for chronic low back pain within 1 month of screening * Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame * Has back pain due to or associated with certain types of conditions * Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00325949