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.