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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00765856
• Other study ID #: EN3202 036
• Status: Terminated
• Phase: Phase 3
• Start date: November 17, 2008
• Est. completion date: February 22, 2010

Study information

• Verified date: November 2020
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 22, 2010
• Est. primary completion date: February 22, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Oxymorphone ER
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications

Locations

Country	Name	City	State
United States	The Children's Hospital	Aurora	Colorado
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine	Little Rock	Arkansas
United States	University of Louisville Reserach Foundation, Inc.	Louisville	Kentucky
United States	Taylor Research, LLC	Marietta	Georgia
United States	Tukoi Clinical Research	Miami	Florida
United States	Stanford University School of Medicine	Stanford	California
United States	St. Joseph's Children's Hospital of Tampa	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose	Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary	Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken	Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary	Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose	Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary	Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues	Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary	Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses	Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)