|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02232256 |
|
Date of registration:
|
29/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
CALPXT96 |
|
Scientific title:
|
A Phase 3 Double Blind, Randomized, Placebo Controlled, Cross-Over Trial to Asses the Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain |
|
Date of first enrolment:
|
December 2015 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02232256 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
James Ducharme, MD CM |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
McMaster University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Pain
|
|
Insomnia
|
|
Intervention(s)
|
|
Drug: CALPXT96
|
|
Primary Outcome(s)
|
|
Does nightly use of CALPXT96 improve sleep in patients with CNCP?
[Time Frame: Change from Baseline in PSQ-3 at Days 15, 30, 44, 59 and 74.]
|
|
Does nightly use of CALPXT96 improve sleep in patients with CNCP?
[Time Frame: Change from Baseline in PSQI at Days 30, 44 and 74.]
|
|
Secondary Outcome(s)
|
|
Does CALPXT96 improve functionality as defined by the PDI (or SF12)?
[Time Frame: Change from Baseline in PDI (or SF12) at Days 15, 30, 44, 59 and 74.]
|
|
Does CALPXT96 allow for a decrease in other medications prescribed for pain?
[Time Frame: Change from Baseline at Days 15, 30, 44, 59 and 74.]
|
|
Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?
[Time Frame: Change from Baseline in BPI at Days 15, 30, 44, 59 and 74.]
|
|
Secondary ID(s)
|
|
CALPXT96-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|