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

NCT01206907 | Withdrawn Phase 3 DMC

• 1 other identifier: EN3319-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Pain

Keywords

sickle cell anemia; juvenile rheumatoid arthritis; burn victim; cancer; Chronic pain of malignant or non-malignant etiology

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.

  weekly for 1 month during titration

• Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.

  bi-weekly for 3 months in the maintenance phase

Interventions

oxymorphone IR DRUG

oxymorphone IR liquid

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Chronic Pain; Anemia, Sickle Cell; Arthritis, Juvenile; Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 17, 2012

Record last verified: 2012-08