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A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With MS
This study has been completed.
Study NCT00678795   Information provided by GW Pharmaceuticals Ltd.
First Received: May 14, 2008   Last Updated: July 10, 2008   History of Changes

May 14, 2008
July 10, 2008
August 2002
October 2005   (final data collection date for primary outcome measure)
Assessment of change from baseline in the mean number of incontinence episodes per day [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00678795 on ClinicalTrials.gov Archive Site
  • Episodes of urgency recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
  • Instances of nocturia recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
  • Daily number of incontinence pads used recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
  • Incontinence quality of life (I-QOL) questionnaire [ Time Frame: Performed at baseline and end of study (Week 10) ] [ Designated as safety issue: No ]
  • Subjective symptom 0-10 NRS [ Time Frame: Performed at baseline and end of study (Week 10) ] [ Designated as safety issue: No ]
  • Patient's Global Impression of Change [ Time Frame: End of Study (Week 10) ] [ Designated as safety issue: No ]
Same as current
 
A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With MS
A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.

Phase III
Interventional
Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Detrusor Overactivity
  • Multiple Sclerosis
  • Drug: Sativex®
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
135
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to give informed consent.
  • Male or female, aged 18 years or over.
  • Diagnosed with MS and with detrusor overactivity not wholly relieved by current therapy.
  • At least three incontinence episodes within five consecutive days during the baseline period
  • Stable dose of anticholinergic medication for at least 14 days leading to study entry.
  • Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception is used during the study and for three months thereafter.
  • Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabinoids during the study.
  • Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.

Exclusion Criteria:

  • A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes due to MS.
  • Using ISC.
  • A history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
  • A history of alcohol or substance abuse.
  • A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
  • A history of epilepsy.
  • If female, are pregnant of lactating, or are planning a pregnancy to occur during the course of the study.
  • Significant renal or hepatic impairment.
  • Elective surgery or other procedures requiring general anesthesia scheduled to occur during the study.
  • Terminal illness or any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the result of the study, or the subjects ability to participate in the study.
  • Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide) within the seven days leading up to study entry.
  • Receiving and unwilling to stop fentanyl for the duration of the study.
  • Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
  • Intention to travel internationally or to donate blood during the study.
  • Participation in another research study in the 12 weeks leading up to study entry.
  • Previous randomization in to this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00678795
Richard Potts Clinical Operation Director, GW Pharmaceuticals Ltd.
GWMS0208
GW Pharmaceuticals Ltd.
 
Principal Investigator: Cris Constantinescu, MD PhD Division of Clinical Neurology, Queen's Medical Centre
GW Pharmaceuticals Ltd.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP