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Open Label Assessment of Long-Term Safety and Utility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904449
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxymorphone ER Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label Drug: Oxymorphone ER
10mg, 20mg, and 40mg PO


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of AEs and clinical laboratory values [ Time Frame: 22 months ]

Secondary Outcome Measures :
  1. Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer [ Time Frame: 22 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904449


Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Study Director Endo Pharmaceuticals
More Information
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Responsible Party: Sr. Director Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00904449    
Other Study ID Numbers: EN3202-022
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia