Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01192295
First received: August 30, 2010
Last updated: March 16, 2015
Last verified: March 2015
Results First Received: January 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Oxycodone HCl controlled-release tablets

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient First Visit: 28-Feb-2011; Last Patient Last Visit: 29-Jul-2014. The study was conducted at medical/research sites in the United States, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
6 to < 12 Years Children 6 to < 12 years of age
≥ 12 to ≤ 16 Years Children ≥ 12 to ≤ 16 years of age

Participant Flow:   Overall Study
    6 to < 12 Years     ≥ 12 to ≤ 16 Years  
STARTED     27     128  
COMPLETED     17     105  
NOT COMPLETED     10     23  
Adverse Event                 3                 7  
Withdrawal by Subject                 3                 4  
Lost to Follow-up                 0                 1  
Lack of Efficacy                 0                 5  
Administrative                 4                 6  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population was the group of patients who received at least 1 dose of study drug during the study.

Reporting Groups
  Description
6 to < 12 Years Children 6 to < 12 years of age
≥ 12 to ≤ 16 Years Children ≥ 12 to ≤ 16 years of age
Total Total of all reporting groups

Baseline Measures
    6 to < 12 Years     ≥ 12 to ≤ 16 Years     Total  
Number of Participants  
[units: participants]
  27     128     155  
Age  
[units: years]
Mean (Standard Deviation)
  9.6  (1.65)     14.5  (1.34)     13.7  (2.33)  
Gender  
[units: participants]
     
Female     14     75     89  
Male     13     53     66  
Race/Ethnicity, Customized  
[units: participants]
     
White     20     88     108  
Black or African American     7     31     38  
Asian     0     1     1  
Other     0     8     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Participants With Adverse Events as a Measure of Safety.   [ Time Frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). ]

2.  Secondary:   Pain Right Now Assessment by Patients Aged 6 to < 12 Years   [ Time Frame: Baseline to week 4 ]

3.  Secondary:   Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years   [ Time Frame: Baseline to week 4 ]

4.  Secondary:   Use of Supplemental Pain Medication   [ Time Frame: Baseline to week 4 ]

5.  Secondary:   Parent/ Caregiver-Assessed Global Impression of Change (PGIC)   [ Time Frame: Baseline to week 4 or early discontinuation ]

6.  Secondary:   Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years   [ Time Frame: Baseline to week 4 ]

7.  Secondary:   Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years   [ Time Frame: Baseline to week 4 ]

8.  Secondary:   Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets   [ Time Frame: Day 1, week 2, and week 4 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
phone: 800-733-1333


No publications provided


Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01192295     History of Changes
Other Study ID Numbers: OTR3001, 2010-020471-23
Study First Received: August 30, 2010
Results First Received: January 22, 2015
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
New Zealand: Medsafe
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Romania: Ministry of Public Health
Guatemala: Ministry of Public Health and Social Assistance
Spain: Agencia Española de Medicamentos y Productos Sanitarios