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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01369615
• Date of registration: 07/06/2011
• Primary sponsor: Purdue Pharma LP
• Public title: Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
• Scientific 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
• Date of first enrolment: October 2011
• Target sample size: 135
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01369615
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel, United States

Contacts

• Name: Eduardo Rodenas, MD

Key inclusion & exclusion criteria

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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Oxycodone hydrochloride controlled-release tablets

Primary Outcome(s)

The number of participants with adverse events as a measure of safety. [Time Frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).]

Secondary ID(s)

2011-002235-26

OTR3002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors