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

NCT02232256 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-04-26

No results posted yet for this study

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

Interventions

DRUG

CALPXT96

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

Sponsors & Collaborators

Principal Investigators

  • James Ducharme, MD CM · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232256 on ClinicalTrials.gov