The Evaluation Of ALO-02 (Oxycodone Hcl and Naltrexone Hcl) In Subjects With Moderate To Severe Chronic Low Back Pain
This study is currently recruiting participants.
Verified October 2012 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01571362
First received: April 3, 2012
Last updated: October 8, 2012
Last verified: October 2012
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Purpose
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Condition | Intervention | Phase |
---|---|---|
Chronic Pain |
Drug: ALO-02 Drug: Placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | A Multicenter, 12-Week, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of ALO-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended Release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain |
Resource links provided by NLM:
Drug Information available for:
Oxycodone
Oxycodone hydrochloride
Naltrexone
Naltrexone hydrochloride
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in baseline in daily average pain numerical rating scale scores [ Time Frame: Baseline, weeks 11 and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent reduction in daily average pain numerical rating scale scores [ Time Frame: Screening, Weeks 11 and 12 ] [ Designated as safety issue: No ]
- Changes in Brief Pain Inventory-Short Form [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Brief Pain Inventory-Short Form [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Brief Pain Inventory-Short Form [ Time Frame: Screening, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Area Under the Curve of the daily average pain numerical rating scale scores [ Time Frame: Screening, Weeks 11 and 12 ] [ Designated as safety issue: No ]
- Amount of acetaminophen [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
- Time to loss of analgesic response [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Time to treatment discontinuation [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Changes in Roland Morris Disability Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Roland Morris Disability Questionnaire [ Time Frame: Baseline, weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Roland Morris Disability Questionnaire [ Time Frame: Screening, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Patient's Global Assessment of Low Back Pain [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Patient's Global Assessment of Low Back Pain [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- Percent of subjects satisfied with treatment [ Time Frame: Randomization, Week 12 ] [ Designated as safety issue: No ]
- Changes in Short-Form-36v2 Health Survey [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Short-Form-36v2 Health Survey [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Changes in Short-Form-36v2 Health Survey [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
- Changes in EQ-5D Health Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in EQ-5D Health Questionnaire [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Changes in EQ-5D Health Questionnaire [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
- Changes in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Screening, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Healthcare Resource Use Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
- Change from baseline in Healthcare Resource Use Questionnaire [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- Changes in Healthcare Resource Use Questionnaire [ Time Frame: Screening, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
- mean and median total daily dose of ALO-02 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- percentage of Chronic Low Back Pain Responder Index [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 250 |
Study Start Date: | June 2012 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: ALO-02 |
Drug: ALO-02
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
Other Name: oxycodone HCl and naltrexone HCl
|
Placebo Comparator: Placebo |
Drug: Placebo
oral placebo, divided into symmetric doses and administered twice daily
Other Name: placebo
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate to severe chronic low back pain present for at least 3 months.
- Require a continuous around-the-clock opioid analgesic for an extended period of time.
- Refrain from taking opioids and non-opioid analgesics during the study.
Exclusion Criteria:
- Active or history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as cancer, infection, spinal stenosis or post-surgical intervention.
- Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfer with assessment of chronic low back pain.
- Active or ongoing or history of alcohol or drug abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571362
Show 53 Study Locations
Contacts
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 53 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Additional Information:
No publications provided
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01571362 History of Changes |
Other Study ID Numbers: | B4531002, B4531002 |
Study First Received: | April 3, 2012 |
Last Updated: | October 8, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
oxycodone naltrexone chronic pain low back pain |
Additional relevant MeSH terms:
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Naltrexone Oxycodone Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics Analgesics, Opioid |
ClinicalTrials.gov processed this record on October 17, 2012