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Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

This study has been terminated.
(the study was stopped due to non-availability of 4mg)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01648699
First received: July 20, 2012
Last updated: October 1, 2013
Last verified: October 2013
Results First Received: March 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Osmotic Release Oral System (OROS) hydromorphone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Osmotic Release Oral System (OROS) Hydromorphone Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.

Participant Flow:   Overall Study
    Osmotic Release Oral System (OROS) Hydromorphone  
STARTED     20  
COMPLETED     15  
NOT COMPLETED     5  
Death                 1  
Lost to Follow-up                 2  
Unspecified/unable to complete 4 visits                 2  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Osmotic Release Oral System (OROS) Hydromorphone Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.

Baseline Measures
    Osmotic Release Oral System (OROS) Hydromorphone  
Number of Participants  
[units: participants]
  20  
Age  
[units: Years]
Mean ± Standard Deviation
  50.35  ± 11.03  
Gender  
[units: Participants]
 
Female     16  
Male     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Pain Inventory (BPI) Average Score at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Brief Pain Inventory (BPI) Average Score at Day 28   [ Time Frame: Day 28 ]

3.  Secondary:   Number of Participants Given Rescue Pain Medications   [ Time Frame: Day 28 ]

4.  Secondary:   Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician   [ Time Frame: Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study was prematurely terminated due to administrative reason.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Medical Affairs Manager
Organization: Janssen Philippines
phone: +632-8248935


No publications provided


Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01648699     History of Changes
Other Study ID Numbers: CR016351, 42801PAI4008
Study First Received: July 20, 2012
Results First Received: March 15, 2013
Last Updated: October 1, 2013
Health Authority: Philippines : Food and Drug Administration