Open Label Assessment of Long-Term Safety and Utility

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904449
First received: May 15, 2009
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Oxymorphone ER
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Assessment of AEs and clinical laboratory values [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
N/A
Drug: Oxymorphone ER
10mg, 20mg, and 40mg PO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904449

Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00904449     History of Changes
Other Study ID Numbers: EN3202-022
Study First Received: May 15, 2009
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Oxymorphone
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014