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Completed

NCT Number: NCT00325949

A Study of Pain Relief in Low Back Pain

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

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Key information

Conditions

Chronic Low Back Pain

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Ref # / Investigator 2216, Hueytown, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended release hydrocodone and acetaminophen (Vicodin CR)

Drug

2 tablets BID

Other names: hydrocodone / acetaminophen extended release

hydrocodone/acetaminophen extended release (Vicodin CR)

Drug

1 tablet BID

Other names: hydrocodone/acetaminophen extended release

Placebo

Drug

2 tablets BID

Primary outcomes

  1. Pain Intensity Difference from randomization baseline to each subject's final assessment

    Time frame: 12 Weeks

    Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)

Secondary outcomes

  1. Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period

  2. Pain Intensity Difference from randomization baseline to each scheduled assessment

  3. Global Assessments of Study Drug and Back Pain Status

  4. Roland-Morris Disability Questionnaire

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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 (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 15, 2006
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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