Status:
COMPLETED
Open Label Assessment of Long-Term Safety and Utility
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00904449
Start Date
April 1 2001
End Date
December 1 2002
Last Update
February 10 2010
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