Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00980798
First received: September 18, 2009
Last updated: May 18, 2011
Last verified: March 2011
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
Osteoarthritis, Hip
Osteoarthritis, Knee
Interventions: Drug: OROS hydromorphone HCl
Drug: Placebo

  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
The first subject attended the first study visit on 05 October 2007, and the last subject completed the last study visit on 24 November 2008.

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
Placebo Placebo daily for 16 weeks
OROS Hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks

Participant Flow:   Overall Study
    Placebo     OROS Hydromorphone HCl  
STARTED     149     139  
COMPLETED     116     84  
NOT COMPLETED     33     55  
Adverse Event                 7                 36  
Lack of Efficacy                 16                 5  
Lost to Follow-up                 0                 1  
Physician Decision                 2                 1  
Withdrawal by Subject                 8                 11  
Other                 0                 1  



  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
Placebo Placebo daily for 16 weeks
OROS Hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     OROS Hydromorphone HCl     Total  
Number of Participants  
[units: participants]
  149     139     288  
Age  
[units: years]
Mean ± Standard Deviation
  64.9  ± 10.37     65.1  ± 9.96     65  ± 10.16  
Gender  
[units: participants]
     
Female     101     107     208  
Male     48     32     80  



  Outcome Measures
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1.  Primary:   Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)   [ Time Frame: At each study visit from screening to week 16 ]

2.  Secondary:   The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event   [ Time Frame: At each study visit from baseline until week 16 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
Concomitant and rescue medication were permitted in the study. This may be why the results in the placebo arm so closely resemble those in the treatment arm. Patients were also less severely impacted by the underlying disease than in other studies.  


Results Point of Contact:  
Name/Title: EMEA Medical Affairs Director Analgesia
Organization: Janssen-Cilag Ireland
phone: 0035 878 339174


No publications provided


Responsible Party: EMEA Medical Affairs Director Analgesia, Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00980798     History of Changes
Other Study ID Numbers: CR012601, HOP Trial
Study First Received: September 18, 2009
Results First Received: August 12, 2010
Last Updated: May 18, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment