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

April 3, 2012
August 4, 2014
June 2012
June 2013   (final data collection date for primary outcome measure)
Change in baseline in daily average pain numerical rating scale scores [ Time Frame: Baseline, weeks 11 and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01571362 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Chronic Pain
  • Low Back Pain
  • Analgesia
  • 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
  • Drug: Placebo
    oral placebo, divided into symmetric doses and administered twice daily
    Other Name: placebo
  • Experimental: ALO-02
    Intervention: Drug: ALO-02
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01571362
B4531002, B4531002
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP