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

NCT00765856 | Terminated Phase 3 Results

• 1 other identifier: EN3202 036
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Chronic Pain

Keywords

Opioid tolerant; Pediatric; Male 6-17 years of age; Female 6-17 years of age; Pain; Non malignant; Malignant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken

  Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

• Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose

  Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

• Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues

  Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

• Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses

  Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

Study Arms (1)

Oxymorphone ER

EXPERIMENTAL

Drug: Oxymorphone ER

Interventions

Oxymorphone ER DRUG

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

Also known as: Opana ER, Opana

Oxymorphone ER

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (13)

Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine

Little Rock, Arkansas, 72202, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Institute of Medical Research

Jacksonville, Florida, 32257, United States

Location

Tukoi Clinical Research

Miami, Florida, 34104, United States

Location

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33618, United States

Location

Taylor Research, LLC

Marietta, Georgia, 30060, United States

Location

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

University of Louisville Reserach Foundation, Inc.

Louisville, Kentucky, 40202, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17112, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Oxymorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Saji Vijayan, MBBS
• Organization: Endo Pharmaceuticals

clinicaltrials@endo.com

800-462-3636

Study Officials

• Sr. Director CR&D

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: November 17, 2008
• Primary Completion: February 22, 2010
• Study Completion: February 22, 2010
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-11

Locations

US (13)