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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


Phase 3
6 Years
17 Years
Open (Enrolling)
Both
Pain

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The number of participants with adverse events as a measure of safety.

Outcome Time Frame:

Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

OTR3002

NCT ID:

NCT01369615

Start Date:

October 2011

Completion Date:

March 2014

Related Keywords:

  • Pain
  • Malignant pain
  • Nonmalignant pain
  • Pain
  • Pediatric
  • Opioid
  • Moderate to severe

Name

Location

Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Akron Children's HospitalAkron, Ohio  44308-1062
Children's Medical Center of DallasDallas, Texas  75235
Children's Hospital of AlabamaBirmingham, Alabama  35233
University of KentuckyLexington, Kentucky  40536-0098
Stony Brook University HospitalStony Brook, New York  11794-8174
New York University Langone Medical CenterNew York, New York  10016
Lynn Health Sciences InstituteOklahoma City, Oklahoma  73112
Lynn Institute of the RockiesColorado Springs, Colorado  80909
Monroe Carell Jr. Children's Hospital at VanderbiltNashville, Tennessee  37232
Children's Hospital ColoradoAurora, Colorado  80045
Bayview Research Group, LLCParamount, California  90723
Mercy Clinic Children's Cancer and Hematology CenterSt. Louis, Missouri  63141
Presbyterian Blume Pediatric Hematology & Oncology ClinicCharlotte, North Carolina  28204
The Children's Hospital at Oklahoma University Medical CenterOklahoma City, Oklahoma  73104