Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine (GWMD09126)

This study has been terminated.
(The Chief Investigator and the Sponsor have concluded that it will not be possible to complete the enrolment in any meaningful timeframe.)
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01491490
First received: December 5, 2011
Last updated: December 16, 2013
Last verified: November 2013
Results First Received: August 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: GWP42003 : GWP42004 (40:1)
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
Recruitment was problematic due to the restrictive entry criteria (one subject screened in the first 5 months). Even after implementation of a protocol amendment to improve recruitment, only 12 subjects were screened and two randomised. It was decided that it would be impossible to complete the study in a meaningful timeframe so it was terminated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were a high proportion of screen failures due to most subjects failing to comply with one or more of the eligibility criteria.

Reporting Groups
  Description
GWP42003 : GWP42004 (40:1) Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo Taken as 6 capsules, matched to taste and look like the active study medication.

Participant Flow:   Overall Study
    GWP42003 : GWP42004 (40:1)     Placebo  
STARTED     1     1  
COMPLETED     1     1  
NOT COMPLETED     0     0  



  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.
Only two subjects of a planned 60 were randomised due to early termination of the study due to problems with recruitment.

Reporting Groups
  Description
GWP42003 : GWP42004 (40:1) Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo Taken as 6 capsules once daily, matched to taste and look like the active study medication.
Total Total of all reporting groups

Baseline Measures
    GWP42003 : GWP42004 (40:1)     Placebo     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24  ± NA [1]   37  ± NA [1]   30.5  ± 6.5  
Gender  
[units: participants]
     
Female     1     1     2  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United Kingdom     1     1     2  
[1] Only 1 participant contributed to the mean.



  Outcome Measures

1.  Primary:   Change in Bodyweight.   [ Time Frame: 6 weeks from Baseline. ]


  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
Early termination due to low subject recruitment meant only two subjects were randomised; one to active and the other to placebo. Only safety data of these two subjects has been reported.


  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 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: Mr Colin Stott
Organization: GW Pharma Ltd.
phone: +44 (0)1980 557000
e-mail: cgs@gwpharm.com


No publications provided


Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01491490     History of Changes
Other Study ID Numbers: GWMD09126
Study First Received: December 5, 2011
Results First Received: August 28, 2013
Last Updated: December 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency