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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980798
Recruitment Status : Completed
First Posted : September 21, 2009
Results First Posted : September 6, 2010
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
Osteoarthritis, Hip
Osteoarthritis, Knee
Interventions: Drug: OROS hydromorphone HCl
Drug: Placebo

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 149   139   288 
[Units: Years]
Mean (Standard Deviation)
 64.9  (10.37)   65.1  (9.96)   65  (10.16) 
[Units: Participants]
Female   101   107   208 
Male   48   32   80 

  Outcome Measures

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

  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.

  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: EMEA Medical Affairs Director Analgesia
Organization: Janssen-Cilag Ireland
phone: 0035 878 339174

Responsible Party: Janssen-Cilag International NV Identifier: NCT00980798     History of Changes
Other Study ID Numbers: CR012601
HOP Trial
First Submitted: September 18, 2009
First Posted: September 21, 2009
Results First Submitted: August 12, 2010
Results First Posted: September 6, 2010
Last Update Posted: April 25, 2014