The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 are a well-recognized component of chronic pain, and lead to additional social withdrawal, greater pain and worsening depression. Most hypnotics available either place the patient at further risk (e.g. benzodiazepines combined with opioids increase the risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid adverse effects while improving sleep. An open-label clinical trial was performed to obtain preliminary safety and efficacy information of California poppy. This trial was approved by a central ethics review board. The study results showed that California poppy, can be used as a co-analgesic to provide additional analgesia and/or sleep improvement to the patient. Patients who are referred to the clinic will be asked to complete a few short questionnaires at every visit and on monthly basis respectively. This data, in addition to the usual follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain Disability Index, Short-form Health Survey-12v2) and general demographic and medical information will be used to assess California Poppy's effectiveness on patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 9305-9954 Quebec Inc
• Collaborator: McMaster University

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 (generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history