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

NCT ID: NCT00765856

Last Updated: 2020-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-17

Study Completion Date

2010-02-22

Brief Summary

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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.

Detailed Description

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

Conditions

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Chronic Pain

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxymorphone ER

Group Type EXPERIMENTAL

Oxymorphone ER

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Opana ER, Opana

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sr. Director CR&D

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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

Little Rock, Arkansas, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

The Children's Hospital

Aurora, Colorado, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Children's National Medical Center

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

Site Status

Florida Institute of Medical Research

Jacksonville, Florida, United States

Site Status

Tukoi Clinical Research

Miami, Florida, United States

Site Status

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, United States

Site Status

Taylor Research, LLC

Marietta, Georgia, United States

Site Status

Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

Site Status

University of Louisville Reserach Foundation, Inc.

Louisville, Kentucky, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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EN3202 036

Identifier Type: -

Identifier Source: org_study_id