Status:
WITHDRAWN
The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
Lead Sponsor:
9305-9954 Quebec Inc
Collaborating Sponsors:
McMaster University
Conditions:
Chronic Pain
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild sedative and/or sleep aid. However there are no human clinical trial data to support its use. Sleep disturbances a...
Detailed Description
Study Design: This will be an 'n of 1' model, with the patient acting as their own control. To identify any possible negative 'wash out' effect after cessation of the active medication (that could ne...
Eligibility Criteria
Inclusion
- Age \> 17 and \< 75
- Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. Validated tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a suitable cut points (PSQI \>/=5) to ensure greater homogeneity of the sample and the recruitment of only those with significant pain related sleep disturbance.
- Stable pain management therapy for 1 month prior to entry into the study
- Having a confirmed diagnosis of CNCP for greater than 1 year
- Written informed consent obtained.
- Subject agreed to follow the protocol.
Exclusion
- Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are willing to cease any current hypnotic for at least 2 weeks prior to commencing the study
- Current alcohol abuse or other addiction
- Sleep apnea disorder
- Inability to understand and comply with the instructions of the study
- Previous enrollment in the study
- Renal and/or liver insufficiency
- Patients less than age 18
- Pregnancy or lactation
- Current (\</=one year) DSM-IV Axis I diagnosis of major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02232256
Start Date
December 1 2015
End Date
December 1 2016
Last Update
April 26 2017
Active Locations (1)
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1
CPM - Centres for Pain Managemen
Mississauga, Ontario, Canada, L5N 3E7