Pain
Conditions
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.
Interventions
DRUGOxymorphone ER
10mg, 20mg, and 40mg PO
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of AEs and clinical laboratory values | 22 months |
Secondary
| Measure | Time frame |
|---|---|
| Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer | 22 months |
Outcome results
None listed