NCT00904449

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Apr 2001

Typical duration for phase_3 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

May 15, 2009

Last Update Submit

February 9, 2010

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Assessment of AEs and clinical laboratory values

    22 months

Secondary Outcomes (1)

  • Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer

    22 months

Study Arms (1)

Open Label

EXPERIMENTAL
Drug: Oxymorphone ER

Interventions

Oxymorphone ERDRUG

10mg, 20mg, and 40mg PO

Open Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Study Director

    Endo Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

April 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

February 10, 2010

Record last verified: 2010-02