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OpenTrials
Completed

NCT Number: NCT00904449

Open Label Assessment of Long-Term Safety and Utility

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxymorphone ER

Drug

10mg, 20mg, and 40mg PO

Primary outcomes

  1. Assessment of AEs and clinical laboratory values

    Time frame: 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

    Time frame: 22 months

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 19, 2009
Registry last updated
Feb 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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