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

NCT02232256 | Withdrawn Phase 3

• 1 other identifier: CALPXT96-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Conditions

Chronic Pain; Insomnia

Keywords

Chronic non-cancer pain; Insomnia; California poppy; Eschscholzia californica; Pain; Sleep quality

Outcome Measures

Primary Outcomes (2)

• Does nightly use of CALPXT96 improve sleep in patients with CNCP?

  Changes in quality of sleep as measured by the the Pittsburgh Sleep Quality Index (PSQI).

  Change from Baseline in PSQI at Days 30, 44 and 74.

• Does nightly use of CALPXT96 improve sleep in patients with CNCP?

  Changes in quality of sleep as measured by the Pain and Sleep Questionnaire (PSQ-3).

  Change from Baseline in PSQ-3 at Days 15, 30, 44, 59 and 74.

Secondary Outcomes (3)

• Does CALPXT96 improve functionality as defined by the PDI (or SF12)?

  Change from Baseline in PDI (or SF12) at Days 15, 30, 44, 59 and 74.

• Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?

  Change from Baseline in BPI at Days 15, 30, 44, 59 and 74.

• Does CALPXT96 allow for a decrease in other medications prescribed for pain?

  Change from Baseline at Days 15, 30, 44, 59 and 74.

Study Arms (2)

CALPXT96

EXPERIMENTAL

1. 1st treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime) 2. 2 week wash out period 3. 2nd treatment period: 4 weeks placebo (two capsules hs at bedtime)

Drug: CALPXT96

Placebo

PLACEBO COMPARATOR

1. 1st treatment period: 4 weeks placebo (two capsules hs at bedtime) 2. 2 week wash 'out' period 3. 2nd treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)

Drug: CALPXT96

Interventions

CALPXT96 DRUG

Arm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo

Also known as: California poppy standardized extract

CALPXT96; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 9305-9954 Quebec Inc: lead
• McMaster University: collaborator

Study Sites (1)

CPM - Centres for Pain Managemen

Mississauga, Ontario, L5N 3E7, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• James Ducharme, MD CM

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 5, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CA (1)