Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

This study has been terminated.
(Terminated new protocol developed which incorporated Pharmacokinetics)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00765856
First received: October 2, 2008
Last updated: September 27, 2012
Last verified: September 2012

October 2, 2008
September 27, 2012
October 2008
February 2010   (final data collection date for primary outcome measure)
Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00765856 on ClinicalTrials.gov Archive Site
Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Pain
Drug: Oxymorphone IR - Opioid
Opana IR 5mg tablet
Other Name: Opana®
Experimental: Opana® ER
Oxymorphone IR - Opioid
Intervention: Drug: Oxymorphone IR - Opioid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
  • Weigh at least 50 kg
  • Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.

Exclusion Criteria:

  • Have a life expectancy <4 weeks
  • Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
  • Have dysphagia or difficulty swallowing whole tablets
  • Have a previous exposure to oxymorphone
  • Have an ileostomy
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765856
EN3202 036
No
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Study Director: Sr. Director CR&D Endo Pharmaceuticals
Endo Pharmaceuticals
September 2012

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