Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

This study has been terminated.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00365898
First received: August 16, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

August 16, 2006
August 16, 2006
July 2005
Not Provided
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
Same as current
No Changes Posted
  • Patient Global Assessment of Pain Medication
  • Pain Control Questionnaire
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Non-Malignant Pain
Drug: Hydromorphone Hydrochloride Extended-Release
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
380
July 2005
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365898
HMP3011
Not Provided
Not Provided
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
August 2006

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