Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01206907
• Other study ID #: EN3319-301
• Status: Withdrawn
• Phase: Phase 3
• First received: September 17, 2010
• Last updated: August 15, 2012
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2012
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Males or females 2 to =6 years of age, inclusive

2. 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)

3. Expected to continue to require a strong opioid for pain relief for at least 4 months

4. Able to swallow the oxymorphone HCl immediate-release oral liquid

5. 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:

1. Known allergy to, or a significant reaction to, oxymorphone or another opioid

2. Life expectancy <4 months

3. Any clinical condition in the investigator's opinion that would preclude participation

4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study

5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen

6. 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

7. An ileostomy

8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication

9. Investigator anticipates that the subject would be unable to comply with the protocol

10. Parent/legal guardian is unable to complete the subject's daily study medication diary

11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• oxymorphone IR
oxymorphone IR liquid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.		weekly for 1 month during titration	No
Primary	Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.		bi-weekly for three months in the maintenance phase	No
Secondary	Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.		weekly for 1 month during titration	No
Secondary	Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.		bi-weekly for 3 months in the maintenance phase	No