Constipation - FunctionalPhase 2/3NCT06836024
A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation
A Phase 2/3 study testing Actazin chewable tablet, PEG 3350 and Chewable Tablet in people with Constipation - Functional and Constipation, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Constipation - Functional, Constipation, Constipation Aggravated
- What is being tested?
- Actazin chewable tablet, PEG 3350 and Chewable Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 17 years, inclusive; minimum age of 4 years to ensure toileting skills have been acquired and ability to chew and swallow tablets safely.
- Fulfill Rome IV diagnostic criteria for FC;60 Must include ≥2 of the following occurring at least once per week for a minimum of 1 month: (i) ≤2 SBMs/ week; (ii) ≥1 episode of fecal incontinence/week; (iii) retentive posturing; (iv) painful or hard bowel movements; (v) presence of a large fecal mass in the rectum (rectal, abdominal or radiographic exam) and (vi) history of large-diameter stools that can obstruct the toilet.
- Participant and their caregivers agree to exclusively use the laxatives provided as part of the trial for a 4-week period, and refrain from using any additional PEG 3350 or kiwifruit/kiwifruit extracts outside of the trial products.
Who cannot join
- Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)
- Prior enrollment in trial
- Not toilet trained; significantly different FC phenotype than toilet trained children
- Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350
- Chronic health conditions (e.g., urolithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially confound the results of the study
- Prior abdominal surgery involving the luminal GI tract, except hernia repairs
Show all 11Show fewer
- Concomitant use of drugs that are known to affect GI motility (e.g., opioids, domperidone, linaclotide)
- Prior neuropsychiatric or pervasive developmental disorders such as severe non-verbal ASD, major psychiatric disorders (bipolar disorder, schizophrenia, major depression)
- Refractory or severe FC that failed to respond to PEG 3350 and/or require combination of several laxative therapies, manual disimpaction, use of any nerve stimulation or antegrade enemas through a cecostomy or an appendicostomy
- Absence of a parent/guardian for children who are not mature minors
- Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Hamilton Health Sciences
Hamilton, Ontario
Sasha Eskandarian, MSc, mMBA, 416-721-4890, eskandars@hhsc.ca
About this study
Official title: Actazin (Kiwifruit Extract) Versus Polyethylene Glycol 3350 for Maintenance Therapy in Children With Constipation: a Feasibility Randomized Control Trial
The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation.
The main questions it aims to answer are:
Read more
- Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC?
- What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period?
Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC.
Participants will:
Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups:
- Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350
- PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events.
Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes.
Outcomes:
Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate.
Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability.
This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).
Read the detailed description
This pilot feasibility randomized controlled trial aims to evaluate the feasibility and preliminary efficacy of Actazin (kiwifruit extract) versus polyethylene glycol 3350 (PEG 3350) as a maintenance therapy for children with functional constipation (FC). The study follows a double-dummy, quadruple-masked, single-centre design to ensure blinding of participants, caregivers, healthcare providers, and investigators.
The trial will enroll children aged 4 to 17 years diagnosed with functional constipation based on Rome IV criteria, recruited from the emergency department (ED) and outpatient clinics at McMaster Children's Hospital (MCH). The study will examine whether a larger, multi-centre trial is feasible based on recruitment rates, adherence to the intervention, and follow-up retention.
Study Design
This is a randomized, double-dummy, quadruple-masked feasibility trial evaluating Actazin against PEG 3350 for the maintenance management of pediatric FC. Sixty participants will be enrolled and randomized in a 1:1 ratio to either:
Intervention group:
Actazin chewable tablets (600 mg starting dose, titrated up to 2,400 mg daily) + placebo PEG 3350 powder Comparator group: PEG 3350 powder (age-based dose) + placebo Actazin chewable tablets Participants and caregivers, bedside clinicians, outcome assessors, and investigators will all be masked to the treatment allocation. The study will last 4 weeks, followed by an additional 8-week observational follow-up to assess longer-term adherence and clinical effects.
Randomization \& Blinding:
Conducted using block randomization (blocks of 2, 4, or 6) through the Hamilton Health Sciences (HHS) Research Pharmacy. Participants will receive identically packaged drug kits containing either active treatment or placebo.
Data Collection \& Monitoring Participants and caregivers will complete a daily bowel diary electronically. Weekly remote follow-ups (phone or electronic survey) will monitor adherence, medication use, and any adverse events.
The final statistical analysis will include descriptive and exploratory methods, reporting mean differences and confidence intervals for clinical outcomes.
Statistical Analysis Plan
Feasibility analysis will be based on progression criteria:
If all feasibility outcomes meet the predefined thresholds, the trial will proceed to a definitive multi-centre RCT. If one or more outcomes fall below feasibility thresholds, protocol modifications will be considered. Clinical outcomes will be analyzed using linear regression (continuous variables) and logistic regression (binary outcomes). Adverse event rates will be compared between groups using Fisher's exact test. No formal hypothesis testing for efficacy will be conducted, as this is a pilot feasibility trial.
- Being tested
- Actazin chewable tablet, PEG 3350, Chewable Tablet, Maltodextrin (Placebo)
- Keywords
- Functional Constipation, Pediatric Constipation, Actazin, Kiwifruit Extract, Polyethylene Glycol 3350, Laxative Therapy, Randomized Controlled Trial, Feasibility Study, Non-Pharmacologic Treatment, Rome IV Criteria
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actazin chewable tabletDietary supplement
Actazin tablets are tableted non-GMO, freeze-dried, green kiwifruit powder from 100% New Zealand-grown green kiwifruit. Currently, kiwifruit extracts (such as Actazin), are marketed in Canada as a natural supplement. It is safe, bioavailable, and has been previously shown to be well tolerated at doses up to 2400 mg.
PEG 3350Drug
a commonly used over the counter laxative in north America. A stool softener.
Chewable TabletOther
Sorbitol-based placebo chewable tablets made by Pharma NZ. Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets.
Maltodextrin (Placebo)Other
Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive Active Actazin chewable tablets and placebo maltodextrin powder resembling PEG 3350:
1. Actazin oral chewable tablets with a starting dose of 600 mg (1 tablet) and can be titrated up to 2,400 mg (4 tablets).
2. Placebo PEG 3350: Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group. Receives: Dietary Supplement: Actazin chewable tablet; Other: Maltodextrin (Placebo) |
| Group 2 | Active comparator | Participants will receive active comparator as PEG 3350 with a placebo chewable tablet resembling Actazin:
1. PEG 3350 dissolved in 125-250 ml of cold water or juice (daily dose is age based: 4-5 years-2 tsp, 6-12 years-4 tsp; >13 years-5 tsp) and can be titrated by 1 tsp (3.7 grams) daily.57
2. Placebo Actazin oral chewable tablets: Sorbitol-based placebo chewable tablets made by Pharma NZ Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets. Receives: Drug: PEG 3350; Other: Chewable Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
Total number consented / Total number eligible and approached for consent
Measured: 18 months
4-week Follow up rates
Total number of participants who did not complete the 4-week outcome
Measured: 18 months
Adherence to allocated intervention
Total number of participants who received the intervention they were allocated and did not cross over / Total number of participants
Measured: 18 months
Secondary outcomes (5)
Recruitment rate
Number of participants recruited/month
Measured: 18 months
Eligibility criteria
Proportion who are being assessed and treated for constipation, but do not meet Rome IV criteria
Measured: 18 months
Completion of daily bowel diary
Number of missing items on the data collection form / total number of variables collected
Measured: 18 months
Compliance rate
Number of days participants took laxative / 28 days
Measured: 18 months
Palatability
Visual analogue scale with 10 facial hedonic features (0-10)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double dummy design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elyanne Ratcliffe, MD, Principal investigator, Hamilton Health Sciences CorporationMohamed M Eltorki, MBChB, MSc, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836024
- Sponsor's protocol ID
- 20240420-Kiwi
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actazin (Kiwifruit Extract) Versus Polyethylene Glycol 3350 for Maintenance Therapy in Children With Constipation: a Feasibility Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06836024
- Acronym / sponsor ID
- 20240420-Kiwi
- Keywords
- Functional Constipation, Pediatric Constipation, Actazin, Kiwifruit Extract, Polyethylene Glycol 3350, Laxative Therapy, Randomized Controlled Trial, Feasibility Study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- 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.
The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation.
The main questions it aims to answer are:
- Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC?
- What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period?
Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC.
Participants will:
Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups:
- Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350
- PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events.
Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes.
Outcomes:
Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate.
Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability.
This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).
Detailed description
This pilot feasibility randomized controlled trial aims to evaluate the feasibility and preliminary efficacy of Actazin (kiwifruit extract) versus polyethylene glycol 3350 (PEG 3350) as a maintenance therapy for children with functional constipation (FC). The study follows a double-dummy, quadruple-masked, single-centre design to ensure blinding of participants, caregivers, healthcare providers, and investigators.
The trial will enroll children aged 4 to 17 years diagnosed with functional constipation based on Rome IV criteria, recruited from the emergency department (ED) and outpatient clinics at McMaster Children's Hospital (MCH). The study will examine whether a larger, multi-centre trial is feasible based on recruitment rates, adherence to the intervention, and follow-up retention.
Study Design
This is a randomized, double-dummy, quadruple-masked feasibility trial evaluating Actazin against PEG 3350 for the maintenance management of pediatric FC. Sixty participants will be enrolled and randomized in a 1:1 ratio to either:
Intervention group:
Actazin chewable tablets (600 mg starting dose, titrated up to 2,400 mg daily) + placebo PEG 3350 powder Comparator group: PEG 3350 powder (age-based dose) + placebo Actazin chewable tablets Participants and caregivers, bedside clinicians, outcome assessors, and investigators will all be masked to the treatment allocation. The study will last 4 weeks, followed by an additional 8-week observational follow-up to assess longer-term adherence and clinical effects.
Randomization \& Blinding:
Conducted using block randomization (blocks of 2, 4, or 6) through the Hamilton Health Sciences (HHS) Research Pharmacy. Participants will receive identically packaged drug kits containing either active treatment or placebo.
Data Collection \& Monitoring Participants and caregivers will complete a daily bowel diary electronically. Weekly remote follow-ups (phone or electronic survey) will monitor adherence, medication use, and any adverse events.
The final statistical analysis will include descriptive and exploratory methods, reporting mean differences and confidence intervals for clinical outcomes.
Statistical Analysis Plan
Feasibility analysis will be based on progression criteria:
If all feasibility outcomes meet the predefined thresholds, the trial will proceed to a definitive multi-centre RCT. If one or more outcomes fall below feasibility thresholds, protocol modifications will be considered. Clinical outcomes will be analyzed using linear regression (continuous variables) and logistic regression (binary outcomes). Adverse event rates will be compared between groups using Fisher's exact test. No formal hypothesis testing for efficacy will be conducted, as this is a pilot feasibility trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double dummy design
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Actazin chewable tablet, Other: Maltodextrin (Placebo)Participants will receive Active Actazin chewable tablets and placebo maltodextrin powder resembling PEG 3350: 1. Actazin oral chewable tablets with a starting dose of 600 mg (1 tablet) and can be titrated up to 2,400 mg (4 tablets). 2. Placebo PEG 3350: Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group. |
| Group 2 | Active comparator | Drug: PEG 3350, Other: Chewable TabletParticipants will receive active comparator as PEG 3350 with a placebo chewable tablet resembling Actazin: 1. PEG 3350 dissolved in 125-250 ml of cold water or juice (daily dose is age based: 4-5 years-2 tsp, 6-12 years-4 tsp; >13 years-5 tsp) and can be titrated by 1 tsp (3.7 grams) daily.57 2. Placebo Actazin oral chewable tablets: Sorbitol-based placebo chewable tablets made by Pharma NZ Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 4 to 17 years, inclusive; minimum age of 4 years to ensure toileting skills have been acquired and ability to chew and swallow tablets safely.
- Fulfill Rome IV diagnostic criteria for FC;60 Must include ≥2 of the following occurring at least once per week for a minimum of 1 month: (i) ≤2 SBMs/ week; (ii) ≥1 episode of fecal incontinence/week; (iii) retentive posturing; (iv) painful or hard bowel movements; (v) presence of a large fecal mass in the rectum (rectal, abdominal or radiographic exam) and (vi) history of large-diameter stools that can obstruct the toilet.
- Participant and their caregivers agree to exclusively use the laxatives provided as part of the trial for a 4-week period, and refrain from using any additional PEG 3350 or kiwifruit/kiwifruit extracts outside of the trial products.
Key exclusion criteria (11 listed)
- Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)
- Prior enrollment in trial
- Not toilet trained; significantly different FC phenotype than toilet trained children
- Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350
- Chronic health conditions (e.g., urolithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially confound the results of 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 |
|---|---|---|
| Actazin chewable tabletActazin tablets are tableted non-GMO, freeze-dried, green kiwifruit powder from 100% New Zealand-grown green kiwifruit. Currently, kiwifruit extracts (such as Actazin), are marketed in Canada as a natural supplement. It is safe, bioavailable, and has been previously shown to be well tolerated at doses up to 2400 mg. | Dietary supplement | Group 1 |
| PEG 3350a commonly used over the counter laxative in north America. A stool softener. | Drug | Group 2 |
| Chewable TabletSorbitol-based placebo chewable tablets made by Pharma NZ. Those tablets will have a similar appearance to active Actazin but will not taste the same. This is because the taste of Actazin is a non-altered natural kiwi taste. They will be administered in the same dose and manner as the active Actazin oral chewable tablets. | Other | Group 2 |
| Maltodextrin (Placebo)Maltodextrin powder, administered in the same doses and manner as active PEG 3350 group. | Other | Group 1 |
Primary outcome
Consent Rate
Time frame: 18 months
Total number consented / Total number eligible and approached for consent
4-week Follow up rates
Time frame: 18 months
Total number of participants who did not complete the 4-week outcome
Adherence to allocated intervention
Time frame: 18 months
Total number of participants who received the intervention they were allocated and did not cross over / Total number of participants
5 secondary outcomes
Recruitment rate
Time frame: 18 months
Eligibility criteria
Time frame: 18 months
Completion of daily bowel diary
Time frame: 18 months
Compliance rate
Time frame: 18 months
Palatability
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request.
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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.
Elyanne Ratcliffe, MD principal investigator
Hamilton Health Sciences Corporation
Mohamed M Eltorki, MBChB, MSc principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Actazin chewable tablet, PEG 3350 and Chewable Tablet in people with Constipation - Functional and Constipation, run by Hamilton Health Sciences Corporation 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 19 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Redjana Carciumaru, MD (905-521-2100 ext. 75821, carciur@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate (time frame: 18 months). The study lists 3 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 19 Mar 2025.