Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

Pain Clinical Trial

Official title:

An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369615
• Other study ID #: OTR3002
• Secondary ID: 2011-002235-26
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2011
• Last updated: August 26, 2015
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria include:

1. Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;

2. Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;

3. Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

Exclusion Criteria include:

1. Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;

2. Female patients who are pregnant or lactating;

3. Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;

4. Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]);

5. Patients who are contraindicated for the use of opioids;

6. Patients who are currently being maintained on methadone for pain;

7. Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;

8. Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices;

9. Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.

Other protocol specific inclusion/exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone hydrochloride controlled-release tablets
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.

Locations

Country	Name	City	State
Israel	Schneider Children Medical Center of Israel	Petach Tikva
United States	Akron Children's Hospital	Akron	Ohio
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Presbyterian Blume Pediatric Hematology & Oncology Clinic	Charlotte	North Carolina
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Jackson Memorial Hospital	Miami	Florida
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	New York University Langone Medical Center	New York	New York
United States	The Children's Hospital at Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Bayview Research Group, LLC	Paramount	California
United States	Mercy Clinic Children's Cancer and Hematology Center	St. Louis	Missouri
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Adverse Events as a Measure of Safety.	Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.	Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).	No