A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01571362
First received: April 3, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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
Low Back Pain
Analgesia
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:


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 ]

Enrollment: 280
Study Start Date: June 2012
Study Completion Date: June 2013
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 other opioid and non-opioid medications during the study.

Exclusion Criteria:

  • Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
  • Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
  • Active or ongoing or history of alcohol or drug abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571362

  Show 47 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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: August 4, 2014
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
Chronic 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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on September 18, 2014