Clinical trial NCT00365898: Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
Official title: A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Non-Malignant Pain
Keywords: Chronic non-malignant pain, opioid
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

Detailed description: The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.

Eligibility criteria: Inclusion Criteria:

* persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase

Exclusion Criteria:

* Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio
Secondary outcomes:
measure: Patient Global Assessment of Pain Medication
measure: Pain Control Questionnaire
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center 2525 W. Greenway Rd. Suite 114
state: Arizona
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. 2147 NE Coachman Road
state: Florida
city: Ft. Myers
country: United States
facility: LCFP, Inc. 12631 World Plaza Lane Building 54
state: Florida
city: Merritt Island
country: United States
facility: Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials 3212 Cove Bend Drive
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
state: Florida
city: Weston
country: United States
facility: Gold Coast Research 2965 Surrey Lane
state: Florida
city: Greensboro
country: United States
facility: PharmQuest 301 E Wendover Avenue Suite 411
state: North Carolina
city: Cincinnati
country: United States
facility: Hightop Medical Research Center 6103 Hamilton Anenue
state: Ohio
city: Dayton
country: United States
facility: Research Institute of Greater Dayton 1010 Woodman Drive
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates, Inc. 3620 Court Drive
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management-PC 1402 Ninth Ave
state: Pennsylvania
city: Tipton
country: United States
facility: he Tipton Medical & Diagnostic Center #334 Route 220
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians 202 Jacob Murphy Lane
state: Pennsylvania
Study officials:
References: