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Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00716144
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Drug: Talarozole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 176 participants were randomized into the study. This study was conducted at 25 centers located in Ireland, the United Kingdom, the Netherlands, Germany, and Russia from 19 June 2006 to 18 May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants were screened (Visit 1) two weeks prior to randomization (Visit 2) in order to evaluate their eligibility for entry into the trial. At Visit 1, participants signed an informed consent, provided their medical histories, reported their concomitant medication usages, and were evaluated against the inclusion/exclusion criteria.

Reporting Groups
  Description
Placebo Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 0.5 mg Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 1.0 mg Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 2.0 mg Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.

Participant Flow:   Overall Study
    Placebo   R115866 0.5 mg   R115866 1.0 mg   R115866 2.0 mg
STARTED   41   45   45   45 
COMPLETED   32   38   33   33 
NOT COMPLETED   9   7   12   12 
Withdrawal by Subject                4                2                6                6 
Lost to Follow-up                2                2                1                2 
Adverse Event                0                0                0                2 
Non-compliance                1                0                0                0 
Protocol Violation                2                0                1                0 
Physician Decision                0                1                2                2 
Intercurrent illness                0                0                1                0 
Withdrew consent, allowed use of data                0                0                1                0 
Adverse event: left foot pain                0                1                0                0 
Clinical Depression                0                1                0                0 



  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
  Description
Placebo Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 0.5 mg Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 1.0 mg Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
R115866 2.0 mg Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
Total Total of all reporting groups

Baseline Measures
   Placebo   R115866 0.5 mg   R115866 1.0 mg   R115866 2.0 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   45   45   45   176 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 45.9  (12.3)   42.3  (13.3)   47.3  (11.5)   48.2  (12.4)   NA [1] 
[1] Age totals (mean and SD) were not provided in CSR. The raw data for this study is no longer available in any of our statistical systems, despite a thorough search. We are unable to supply this total data as typically required.
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      4   9.8%      2   4.4%      3   6.7%      6  13.3%      15   8.5% 
Male      37  90.2%      43  95.6%      42  93.3%      39  86.7%      161  91.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.4%      0   0.0%      1   2.2%      0   0.0%      2   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      40  97.6%      45 100.0%      44  97.8%      45 100.0%      174  98.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Psoriasis Area Severity Index (PASI)75 Success at Visit 6   [ Time Frame: Week 12 (Visit 6) ]

2.  Secondary:   PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit   [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) ]

3.  Secondary:   Investigator's Global Assessment (IGA) at Each Post Baseline Visit   [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) ]

4.  Secondary:   PASI75 at Each Post Baseline Visit Except Visit 6   [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6) ]


  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
No text entered.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00716144     History of Changes
Other Study ID Numbers: BT0720-201-INT
First Submitted: July 15, 2008
First Posted: July 16, 2008
Results First Submitted: March 10, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018