A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00678795
First received: May 14, 2008
Last updated: June 13, 2013
Last verified: June 2013
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Detrusor Overactivity
Multiple Sclerosis
Interventions: Drug: Sativex®
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
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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
Sativex Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Placebo Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.

Participant Flow:   Overall Study
    Sativex     Placebo  
STARTED     67     68  
COMPLETED     56     62  
NOT COMPLETED     11     6  
Adverse Event                 7                 3  
Withdrawal by Subject                 3                 0  
Protocol Violation                 0                 1  
Lost to Follow-up                 0                 1  
Lack of Efficacy                 1                 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.
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Reporting Groups
  Description
Sativex Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Placebo Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Total Total of all reporting groups

Baseline Measures
    Sativex     Placebo     Total  
Number of Participants  
[units: participants]
  67     68     135  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     63     66     129  
>=65 years     4     2     6  
Age  
[units: years]
Mean ± Standard Deviation
  48.61  ± 9.31     46.79  ± 11.20     47.69  ± 10.31  
Gender  
[units: participants]
     
Female     52     46     98  
Male     15     22     37  
Region of Enrollment  
[units: participants]
     
United Kingdom     35     33     68  
Belgium     23     26     49  
Romania     9     9     18  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment   [ Time Frame: 0 - 10 weeks ]

2.  Secondary:   Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment   [ Time Frame: Daily diary entries throughout 10 week study period ]

3.  Secondary:   Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment   [ Time Frame: 0 - 10 weeks ]

4.  Secondary:   Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment   [ Time Frame: 0 - 10 weeks ]

5.  Secondary:   Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)   [ Time Frame: 0 - 10 weeks ]

6.  Secondary:   Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment   [ Time Frame: 0 - 10 weeks ]

7.  Secondary:   Patient’s Global Impression of Change   [ Time Frame: 0 - 10 weeks ]

8.  Secondary:   Change From Baseline in the Mean Number of Daily Voids at the End of Treatment   [ Time Frame: 0 - 10 weeks ]


  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 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.


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.  


Results Point of Contact:  
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
phone: 0044 1223 266800
e-mail: rp@gwpharm.com


Publications of Results:

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00678795     History of Changes
Other Study ID Numbers: GWMS0208
Study First Received: May 14, 2008
Results First Received: July 18, 2012
Last Updated: June 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment