Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
NCT01428583
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
- Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)
- Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma,
infection, or other pain expected to be short-term (duration less than 3 months).
- Subject has a documented history of alcohol or drug abuse within 1 year prior to study
entry that in the Investigator's judgment would impact subject participation.
- Subject has ongoing or active alcohol or drug abuse that in the Investigator's
judgment would impact subject participation.
- Subject has a positive urine drug test for illicit drug use or medications at
screening without legitimate medical explanation.
- Subject has a clinically significant medical condition (e.g., cardiovascular,
neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological,
immunological, rheumatological, metabolic, or psychiatric) or physical examination,
vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities
that in the opinion of the Investigator would impact the safety of the subject during
study participation.
- If female, the subject is pregnant or breast-feeding.
- Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts,
naltrexone or acetaminophen,or pharmacological similar compounds.
- Subject is historically non-responsive to oxycodone treatment or requires greater than
160 mg oxycodone in a 24-hour time interval.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Gainesville, Florida
- Gainesville, Florida
- Gainesville, Florida
- Gainesville, Florida
- Deland, Florida
- Jacksonville, Florida
- Jupiter, Florida
- Ormond Beach, Florida
- Ormond Beach, Florida
- Port Orange, Florida
- Sarasota, Florida
- Tampa, Florida
- Atlanta, Georgia
- Marietta, Georgia
- Marietta, Georgia
- Lexington, Kentucky
- Madisonville, Kentucky
- Owings Mills, Maryland
- Springfield, Massachusetts
- Edina, Minnesota
- Southaven, Mississippi
- Hazelwood, Missouri
- Missoula, Montana
- Berlin, New Jersey
- Hartsdale, New York
- North Syracuse, New York
- Williamsville, New York
- Winston-Salem, North Carolina
- Columbus, Ohio
- Altoona, Pennsylvania
- Austin, Texas
- Dallas, Texas
- Fort Worth, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Roanoke, Virginia
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain | |||
Official Title ICMJE | A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain | |||
Brief Summary | The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Supportive Care | |||
Condition ICMJE | Chronic Noncancer Pain | |||
Intervention ICMJE | Drug: oxycodone HCl and naltrexone HCl extended-release capsules
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.) Other Name: ALO-02 | |||
Study Arms ICMJE | Experimental: oxycodone HCl and naltrexone HCl extended-release capsules
Intervention: Drug: oxycodone HCl and naltrexone HCl extended-release capsules | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 395 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01428583 | |||
Other Study ID Numbers ICMJE | ALO-02-10-3001 B4531001 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |