Chronic Low Back Pain Clinical Trial
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 (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
| Verified date | July 2011 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 770 |
| Est. completion date | June 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Ref # / Investigator 1975 | Atlanta | Georgia |
| United States | Site Ref # / Investigator 2217 | Austin | Texas |
| United States | Site Ref # / Investigator 3420 | Biloxi | Mississippi |
| United States | Site Ref # / Investigator 2603 | Brockton | Massachusetts |
| United States | Site Ref # / Investigator 1992 | Buena Park | California |
| United States | Site Ref # / Investigator 2607 | Bulverde | Texas |
| United States | Site Ref # / Investigator 1993 | Burbank | California |
| United States | Site Ref # / Investigator 1985 | Chicago | Illinois |
| United States | Site Ref # / Investigator 1987 | Cincinnati | Ohio |
| United States | Site Ref # / Investigator 1995 | Cincinnati | Ohio |
| United States | Site Ref # / Investigator 2218 | Cincinnati | Ohio |
| United States | Site Ref # / Investigator 2208 | Clearwater | Florida |
| United States | Site Ref # / Investigator 1984 | Cordova | Tennessee |
| United States | Site Ref # / Investigator 2137 | Cranston | Rhode Island |
| United States | Site Ref # / Investigator 2590 | Dallas | Texas |
| United States | Site Ref # / Investigator 1991 | Decatur | Georgia |
| United States | Site Ref # / Investigator 2210 | DeLand | Florida |
| United States | Site Ref # / Investigator 2157 | Denver | Colorado |
| United States | Site Ref # / Investigator 2215 | Downingtown | Pennsylvania |
| United States | Site Ref # / Investigator 2579 | Duncansville | Pennsylvania |
| United States | Site Ref # / Investigator 1978 | Evansville | Indiana |
| United States | Site Ref # / Investigator 2219 | Fair Oaks | California |
| United States | Site Ref # / Investigator 2556 | Florissant | Missouri |
| United States | Site Ref # / Investigator 2221 | Greer | South Carolina |
| United States | Site Ref # / Investigator 2207 | Hollywood | Florida |
| United States | Site Ref # / Investigator 2216 | Hueytown | Alabama |
| United States | Site Ref # / Investigator 2117 | Killeen | Texas |
| United States | Site Ref # / Investigator 2206 | Las Vegas | Nevada |
| United States | Site Ref # / Investigator 3421 | Las Vegas | Nevada |
| United States | Site Ref # / Investigator 1989 | Los Gatos | California |
| United States | Site Ref # / Investigator 2213 | Mechanicsburg | Pennsylvania |
| United States | Site Ref # / Investigator 2209 | Metairie | Louisiana |
| United States | Site Ref # / Investigator 2204 | Miami | Florida |
| United States | Site Ref # / Investigator 2205 | Miami | Florida |
| United States | Site Ref # / Investigator 1982 | Missoula | Montana |
| United States | Site Ref # / Investigator 2604 | Nederland | Texas |
| United States | Site Ref # / Investigator 1973 | New York | New York |
| United States | Site Ref # / Investigator 2211 | Oklahoma City | Oklahoma |
| United States | Site Ref # / Investigator 2214 | Oldsmar | Florida |
| United States | Site Ref # / Investigator 1986 | Omaha | Nebraska |
| United States | Site Ref # / Investigator 2203 | Pasadena | Maryland |
| United States | Site Ref # / Investigator 1990 | Phoenix | Arizona |
| United States | Site Ref # / Investigator 2605 | Phoenix | Arizona |
| United States | Site Ref # / Investigator 2135 | Plantation | Florida |
| United States | Site Ref # / Investigator 2580 | Prairie Village | Kansas |
| United States | Site Ref # / Investigator 1983 | Raleigh | North Carolina |
| United States | Site Ref # / Investigator 2606 | Raleigh | North Carolina |
| United States | Site Ref # / Investigator 1979 | Richardson | Texas |
| United States | Site Ref # / Investigator 2212 | San Angelo | Texas |
| United States | Site Ref # / Investigator 1981 | San Antonio | Texas |
| United States | Site Ref # / Investigator 2220 | San Antonio | Texas |
| United States | Site Ref # / Investigator 2608 | San Antonio | Texas |
| United States | Site Ref # / Investigator 1976 | Shreveport | Louisiana |
| United States | Site Ref # / Investigator 1980 | St. Louis | Missouri |
| United States | Site Ref # / Investigator 1974 | Tempe | Arizona |
| United States | Site Ref # / Investigator 1994 | Trumbull | Connecticut |
| United States | Site Ref # / Investigator 1977 | Tucson | Arizona |
| United States | Site Ref # / Investigator 2158 | Virginia Beach | Virginia |
| United States | Site Ref # / Investigator 2156 | Wellesley Hills | Massachusetts |
| United States | Site Ref # / Investigator 1988 | West Des Moines | Iowa |
| United States | Site Ref # / Investigator 2134 | West Palm Beach | Florida |
| United States | Site Ref # / Investigator 2578 | Williamsville | New York |
| United States | Site Ref # / Investigator 5161 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period | |||
| Secondary | Pain Intensity Difference from randomization baseline to each scheduled assessment | |||
| Secondary | Global Assessments of Study Drug and Back Pain Status | |||
| Secondary | Roland-Morris Disability Questionnaire |
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