Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
This study has been withdrawn prior to enrollment.
(The study is no longer required for the PREA for this product.)
Sponsor:
Endo Pharmaceuticals
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01206907
First received: September 17, 2010
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: oxymorphone IR |
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, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. [ Time Frame: weekly for 1 month during titration ] [ Designated as safety issue: No ]
- Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. [ Time Frame: bi-weekly for three months in the maintenance phase ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. [ Time Frame: weekly for 1 month during titration ] [ Designated as safety issue: No ]
- Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. [ Time Frame: bi-weekly for 3 months in the maintenance phase ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: oxymorphone IR
oxymorphone IR liquid
Eligibility| Ages Eligible for Study: | 2 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males or females 2 to ≤6 years of age, inclusive
- Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose >1 mg/kg qd oral morphine equivalent)
- Expected to continue to require a strong opioid for pain relief for at least 4 months
- Able to swallow the oxymorphone HCl immediate-release oral liquid
- Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
Exclusion Criteria:
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy <4 months
- Any clinical condition in the investigator's opinion that would preclude participation
- Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
- Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
- Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
- An ileostomy
- Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
- Investigator anticipates that the subject would be unable to comply with the protocol
- Parent/legal guardian is unable to complete the subject's daily study medication diary
- Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Sr. Director CR & D, Endo Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01206907 History of Changes |
| Other Study ID Numbers: | EN3319-301 |
| Study First Received: | September 17, 2010 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
sickle cell anemia juvenile rheumatoid arthritis burn victim cancer Chronic pain of malignant or non-malignant etiology |
Additional relevant MeSH terms:
|
Oxymorphone Analgesics, Opioid Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 18, 2013