Open Label Assessment of Long-Term Safety and Utility
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904449
First received: May 15, 2009
Last updated: February 9, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Oxymorphone ER |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Assessment of AEs and clinical laboratory values [ Time Frame: 22 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer [ Time Frame: 22 months ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | April 2001 |
| Study Completion Date: | December 2002 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open Label
N/A
|
Drug: Oxymorphone ER
10mg, 20mg, and 40mg PO
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sr. Director Clinical R&D, Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00904449 History of Changes |
| Other Study ID Numbers: | EN3202-022 |
| Study First Received: | May 15, 2009 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Oxymorphone Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013