Open Label Assessment of Long-Term Safety and Utility

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2002-12-31

Brief Summary

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The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.

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Detailed Description

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Conditions

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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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Open Label

Group Type EXPERIMENTAL

Oxymorphone ER

Intervention Type DRUG

10mg, 20mg, and 40mg PO

Interventions

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Oxymorphone ER

10mg, 20mg, and 40mg PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females aged \> 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics.
* Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study.
* Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible.

Exclusion Criteria

* Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication.
* Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication.
* Known idiosyncratic reaction or hypersensitivity to oxymorphone.
* Inability to take oral medication for 1 week.
* Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No