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A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00710424
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : July 31, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Pain
Diabetic Neuropathy
Interventions: Drug: Sativex
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
No text entered.

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 Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.

Participant Flow:   Overall Study
    Sativex   Placebo
STARTED   149   148 
COMPLETED   105   125 
NOT COMPLETED   44   23 
Adverse Event                30                12 
Lack of Efficacy                4                5 
Withdrawal by Subject                5                3 
Lost to Follow-up                0                1 
Refused medication, no side effects                1                0 
Non-compliance with stable analgesia                1                0 
Did not meet entry criteria at visit 1                1                0 
Subject thought medication changed                1                0 
Ceased treatment due to travel                1                0 
Subject preferred paracetamol                0                1 
Felt good so stopped treatment                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
  Description
Sativex Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Total Total of all reporting groups

Baseline Measures
   Sativex   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   148   297 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   97   119   216 
>=65 years   52   29   81 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (10.38)   58.2  (10.57)   59.5  (10.54) 
Gender 
[Units: Participants]
     
Female   56   58   114 
Male   93   90   183 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   91   86   177 
Czech Republic   34   37   71 
Romania   24   25   49 


  Outcome Measures

1.  Primary:   The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)   [ Time Frame: Day 0 to Day 98 ]

2.  Primary:   Number of Responders at the 30% Improvement Level at the End of Treatment   [ Time Frame: Day 0 - Day 98 ]

3.  Secondary:   Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment   [ Time Frame: Day 0 to Day 98 ]

4.  Secondary:   Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment   [ Time Frame: Day 0 - Day 98 ]

5.  Secondary:   Subject Global Impression of Change at the End of Treatment   [ Time Frame: Day 0 and Day 98 ]

6.  Secondary:   Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment   [ Time Frame: Day 0 and Day 98 ]

7.  Secondary:   Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale   [ Time Frame: Day 0 and Day 98 ]

8.  Secondary:   Change From Baseline in the Use of Rescue Analgesia at the End of Treatment   [ Time Frame: Day 0 - Day 98 ]

9.  Secondary:   Incidence of Adverse Events as a Measure of Subject Safety   [ Time Frame: Day 0 - Day 133 ]

10.  Secondary:   Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment   [ Time Frame: Day 0 - Day 98 ]


  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: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharm Ltd
phone: 0044 1223 266800
e-mail: rp@gwpharm.com



Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00710424     History of Changes
Other Study ID Numbers: GWCL0305
First Submitted: July 2, 2008
First Posted: July 4, 2008
Results First Submitted: June 26, 2012
Results First Posted: July 31, 2012
Last Update Posted: August 1, 2012