Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2003-07-31

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

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Detailed Description

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Conditions

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Cancers, Pain Lower Back Pain

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

Open label

Interventions

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Oxymorphone ER

Open label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
* Males or females, age 18 and 75 years, inclusively.
* The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.

Exclusion Criteria

* The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
* The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
* Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes