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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of AEs and clinical laboratory values

Outcome Time Frame:

22 months

Safety Issue:

No

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Endo Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

EN3202-022

NCT ID:

NCT00904449

Start Date:

April 2001

Completion Date:

December 2002

Related Keywords:

  • Pain

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