A Study of Pain Relief in Low Back Pain

NCT00325949 | Completed Phase 3

• 1 other identifier: M05-790
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 63

Brief Summary

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

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

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

  12 Weeks

Secondary Outcomes (4)

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

• Pain Intensity Difference from randomization baseline to each scheduled assessment

• Global Assessments of Study Drug and Back Pain Status

• Roland-Morris Disability Questionnaire

Study Arms (3)

arm label (1) hydrocodone/acetaminophen extended release

EXPERIMENTAL

Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)

arm label (2) hydrocodone/acetaminophen extended release

EXPERIMENTAL

Drug: hydrocodone/acetaminophen extended release (Vicodin CR)

Arm label (3) placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Extended release hydrocodone and acetaminophen (Vicodin CR) DRUG

2 tablets BID

Also known as: hydrocodone / acetaminophen extended release

arm label (1) hydrocodone/acetaminophen extended release

hydrocodone/acetaminophen extended release (Vicodin CR) DRUG

1 tablet BID

Also known as: hydrocodone/acetaminophen extended release

arm label (2) hydrocodone/acetaminophen extended release

placebo DRUG

2 tablets BID

Arm label (3) placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (63)

Site Ref # / Investigator 2216

Hueytown, Alabama, 35023, United States

Location

Site Ref # / Investigator 2605

Phoenix, Arizona, 85023, United States

Location

Site Ref # / Investigator 1990

Phoenix, Arizona, 85029, United States

Location

Site Ref # / Investigator 1974

Tempe, Arizona, 85282, United States

Location

Site Ref # / Investigator 1977

Tucson, Arizona, 85741, United States

Location

Site Ref # / Investigator 1992

Buena Park, California, 90620, United States

Location

Site Ref # / Investigator 1993

Burbank, California, 91505, United States

Location

Site Ref # / Investigator 2219

Fair Oaks, California, 95628, United States

Location

Site Ref # / Investigator 1989

Los Gatos, California, 95032, United States

Location

Site Ref # / Investigator 2157

Denver, Colorado, 80209, United States

Location

Site Ref # / Investigator 1994

Trumbull, Connecticut, 06611, United States

Location

Site Ref # / Investigator 2208

Clearwater, Florida, 33756, United States

Location

Site Ref # / Investigator 2210

DeLand, Florida, 32720, United States

Location

Site Ref # / Investigator 2207

Hollywood, Florida, 33023, United States

Location

Site Ref # / Investigator 2204

Miami, Florida, 33156, United States

Location

Site Ref # / Investigator 2205

Miami, Florida, 33186, United States

Location

Site Ref # / Investigator 2214

Oldsmar, Florida, 34677, United States

Location

Site Ref # / Investigator 2135

Plantation, Florida, 33324, United States

Location

Site Ref # / Investigator 2134

West Palm Beach, Florida, 33409-3509, United States

Location

Site Ref # / Investigator 1975

Atlanta, Georgia, 30328, United States

Location

Site Ref # / Investigator 1991

Decatur, Georgia, 30033, United States

Location

Site Ref # / Investigator 1985

Chicago, Illinois, 60610, United States

Location

Site Ref # / Investigator 1978

Evansville, Indiana, 47714, United States

Location

Site Ref # / Investigator 1988

West Des Moines, Iowa, 50265, United States

Location

Site Ref # / Investigator 2580

Prairie Village, Kansas, 66206, United States

Location

Site Ref # / Investigator 2209

Metairie, Louisiana, 70006, United States

Location

Site Ref # / Investigator 1976

Shreveport, Louisiana, 71103, United States

Location

Site Ref # / Investigator 2203

Pasadena, Maryland, 21122, United States

Location

Site Ref # / Investigator 2603

Brockton, Massachusetts, 02301, United States

Location

Site Ref # / Investigator 2156

Wellesley Hills, Massachusetts, 02481-2106, United States

Location

Site Ref # / Investigator 3420

Biloxi, Mississippi, 39531, United States

Location

Site Ref # / Investigator 2556

Florissant, Missouri, 63031, United States

Location

Site Ref # / Investigator 1980

St Louis, Missouri, 63141, United States

Location

Site Ref # / Investigator 1982

Missoula, Montana, 59802, United States

Location

Site Ref # / Investigator 1986

Omaha, Nebraska, 68134, United States

Location

Site Ref # / Investigator 3421

Las Vegas, Nevada, 89106, United States

Location

Site Ref # / Investigator 2206

Las Vegas, Nevada, 89123, United States

Location

Site Ref # / Investigator 1973

New York, New York, 10022, United States

Location

Site Ref # / Investigator 2578

Williamsville, New York, 14221, United States

Location

Site Ref # / Investigator 1983

Raleigh, North Carolina, 27609, United States

Location

Site Ref # / Investigator 2606

Raleigh, North Carolina, 27612, United States

Location

Site Ref # / Investigator 5161

Winston-Salem, North Carolina, 27103, United States

Location

Site Ref # / Investigator 2218

Cincinnati, Ohio, 45227, United States

Location

Site Ref # / Investigator 1995

Cincinnati, Ohio, 45242, United States

Location

Site Ref # / Investigator 1987

Cincinnati, Ohio, 45245, United States

Location

Site Ref # / Investigator 2211

Oklahoma City, Oklahoma, 73103, United States

Location

Site Ref # / Investigator 2215

Downingtown, Pennsylvania, 19335, United States

Location

Site Ref # / Investigator 2579

Duncansville, Pennsylvania, 16635, United States

Location

Site Ref # / Investigator 2213

Mechanicsburg, Pennsylvania, 17055, United States

Location

Site Ref # / Investigator 2137

Cranston, Rhode Island, 02920, United States

Location

Site Ref # / Investigator 2221

Greer, South Carolina, 29651, United States

Location

Site Ref # / Investigator 1984

Cordova, Tennessee, 38018, United States

Location

Site Ref # / Investigator 2217

Austin, Texas, 78705, United States

Location

Site Ref # / Investigator 2607

Bulverde, Texas, 78163, United States

Location

Site Ref # / Investigator 2590

Dallas, Texas, 75251, United States

Location

Site Ref # / Investigator 2117

Killeen, Texas, 76543, United States

Location

Site Ref # / Investigator 2604

Nederland, Texas, 77627, United States

Location

Site Ref # / Investigator 1979

Richardson, Texas, 75080, United States

Location

Site Ref # / Investigator 2212

San Angelo, Texas, 76904, United States

Location

Site Ref # / Investigator 1981

San Antonio, Texas, 78127, United States

Location

Site Ref # / Investigator 2220

San Antonio, Texas, 78209, United States

Location

Site Ref # / Investigator 2608

San Antonio, Texas, 78218, United States

Location

Site Ref # / Investigator 2158

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Interventions

Acetaminophen; Hydrocodone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rita Jain, M.D.

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 15, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

US (63)