Chronic PainPhase 3CALPXT96NCT02232256
The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
A Phase 3 study testing CALPXT96 in people with Chronic Pain and Insomnia, run by 9305-9954 Quebec Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Insomnia
- What is being tested?
- CALPXT96
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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 negatively impact the 'no drug' arm) we have to do the following. After baseline documentation with standardized scales, randomize to one of 2 arms:
- Arm A
- 1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
- 2 week wash out period
- 2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- Arm B
- 1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- 2 week ash out period
- -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
Objectives:
Primary objective
The primary objective of this study is:
- Does nightly use of CALPXT96 improve sleep in patients with CNCP? Secondary objective
- The secondary objective of this study are:
- Does CALPXT96 improve functionality as defined by the PDI (or Short-Form Health Survey-12 (SF12))?
- Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?
- Does CALPXT96 allow for a decrease in other medications prescribed for pain?
Efficacy Measures
- Changes in quality of seep as measured by the the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ-3).
- Changes in pain intensity scores (Brief Pain Inventory) and changes in functionality and health related quality of life as measured with the Pain Disability Index (PDI) and SF-12v2 respectively.
Population:
Chronic pain patients suffering from CNCP for greater than 1 year, with complaint of poor sleep (defined as >/= 5 on the Pittsburgh Sleep Quality Index (PSQI), aged 18 and up and of a normal mix of gender, age, and socioeconomic status and with a stable pain management treatment for at least one month.
Inclusion Criteria
Subjects are eligible to be included in the study only if they meet all of the following 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
Subjects will be excluded from the study if they meet any of the following 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 (</=one year) Diagnostic and Statistical Manual-IV (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
- Conditions
- Chronic Pain, Insomnia
- Being tested
- CALPXT96
- Keywords
- Chronic non-cancer pain, Insomnia, California poppy, Eschscholzia californica, Pain, Sleep quality
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALPXT96Drug
Also called California poppy standardized extract
Arm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: CALPXT96 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)?
Changes in functionality and health related quality of life as measured with the Pain Disability Index (or SF-12v2).
Measured: 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)?
Changes in pain intensity scores (Brief Pain Inventory).
Measured: 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?
Concomitant and rescue medication
Measured: Change from Baseline at Days 15, 30, 44, 59 and 74.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016
Why it stopped: Site unable to enrol recruited subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 9305-9954 Quebec Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- James Ducharme, MD CM, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232256
- Sponsor's protocol ID
- CALPXT96-01
- Acronym
- CALPXT96
- Status last verified
- Apr 2017
- First submitted
- 29 Aug 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02232256
- Acronym / sponsor ID
- CALPXT96 / CALPXT96-01
- Conditions
- Chronic Pain, Insomnia
- Keywords
- Chronic non-cancer pain, Insomnia, California poppy, Eschscholzia californica, Pain, Sleep quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site unable to enrol recruited subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 9305-9954 Quebec IncIndustry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 negatively impact the 'no drug' arm) we have to do the following. After baseline documentation with standardized scales, randomize to one of 2 arms:
- Arm A
- 1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
- 2 week wash out period
- 2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- Arm B
- 1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- 2 week ash out period
- -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
Objectives:
Primary objective
The primary objective of this study is:
- Does nightly use of CALPXT96 improve sleep in patients with CNCP? Secondary objective
- The secondary objective of this study are:
- Does CALPXT96 improve functionality as defined by the PDI (or Short-Form Health Survey-12 (SF12))?
- Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?
- Does CALPXT96 allow for a decrease in other medications prescribed for pain?
Efficacy Measures
- Changes in quality of seep as measured by the the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ-3).
- Changes in pain intensity scores (Brief Pain Inventory) and changes in functionality and health related quality of life as measured with the Pain Disability Index (PDI) and SF-12v2 respectively.
Population:
Chronic pain patients suffering from CNCP for greater than 1 year, with complaint of poor sleep (defined as >/= 5 on the Pittsburgh Sleep Quality Index (PSQI), aged 18 and up and of a normal mix of gender, age, and socioeconomic status and with a stable pain management treatment for at least one month.
Inclusion Criteria
Subjects are eligible to be included in the study only if they meet all of the following 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
Subjects will be excluded from the study if they meet any of the following 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 (</=one year) Diagnostic and Statistical Manual-IV (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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALPXT96 | Experimental | Drug: CALPXT961. 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) |
| Placebo | Placebo comparator | Drug: CALPXT961. 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALPXT96Also: California poppy standardized extractArm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo | Drug | CALPXT96, Placebo |
Primary outcome
Does nightly use of CALPXT96 improve sleep in patients with CNCP?
Time frame: Change from Baseline in PSQI at Days 30, 44 and 74.
Changes in quality of sleep as measured by the the Pittsburgh Sleep Quality Index (PSQI).
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.
Changes in quality of sleep as measured by the Pain and Sleep Questionnaire (PSQ-3).
3 secondary outcomes
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 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?
Time frame: 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?
Time frame: Change from Baseline at Days 15, 30, 44, 59 and 74.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ducharme, MD CM principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CALPXT96 in people with Chronic Pain and Insomnia, run by 9305-9954 Quebec Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does nightly use of CALPXT96 improve sleep in patients with CNCP? (time frame: Change from Baseline in PSQI at Days 30, 44 and 74.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.