Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001179729
Ethics application status
Approved
Date submitted
28/07/2022
Date registered
1/09/2022
Date last updated
1/09/2022
Date data sharing statement initially provided
1/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS)
Scientific title
SC3PO: A double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS)
Secondary ID [1] 307657 0
N/A
Universal Trial Number (UTN)
Trial acronym
GENESIS STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome (IBS) 327167 0
Condition category
Condition code
Oral and Gastrointestinal 324303 324303 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants suffering abdominal pain from IBS will be administered cannabis CBD oil or a matching placebo oil, in an oral liquid. The dose administered will be 50mg twice daily for a total of 100mg/day of CBD. This duration will last four weeks.

The strategy used to monitor adherence to dosing will be the deployment of a daily dosing diary. Also, the bottle is 30ml, and with 1ml (100mg/CBD) to be taken daily, each participant cannot exceed the recommended dose.
Intervention code [1] 324116 0
Treatment: Drugs
Comparator / control treatment
The placebo is only medium chain triglyceride oil and contains beta-carotene used as a colouring agent to match the investigational product.
Control group
Placebo

Outcomes
Primary outcome [1] 332130 0
The primary outcome is to assess any change in abdominal pain assessed by utilising a validated IBS Symptom Severity Scale questionnaire.
Timepoint [1] 332130 0
14 days post-commencement of intervention and 28 days post-commencement of intervention (primary).
Secondary outcome [1] 412308 0
The outcome is to assess any change in sleep assessed by utilising the validated Leeds Sleep Evaluation Questionnaire.
Timepoint [1] 412308 0
14 days post-commencement of intervention and 28 days post-commencement of intervention.
Secondary outcome [2] 412497 0
The outcome is to assess any change in nausea assess by utilising a Numerical Analogue Scale from 0 - 10.
Timepoint [2] 412497 0
14 days post-commencement of intervention and 28 days post-commencement of intervention.
Secondary outcome [3] 412498 0
The outcome is to assess any change in Quality of Life by utilising the free validated questionnaire SF-12 Short Form Health Survey.
Timepoint [3] 412498 0
14 days post-commencement of intervention and 28 days post-commencement of intervention.
Secondary outcome [4] 412499 0
The outcome is to assess any change in anxiety assess by utilising a Numerical Analogue Scale from 0 - 10.
Timepoint [4] 412499 0
14 days post-commencement of intervention and 28 days post-commencement of intervention.

Eligibility
Key inclusion criteria
- 18 years of age and over to a maximum of 70 years of age at the time of consent;
- Meets Rome IV criteria for IBS of any subtype [IBS with constipation (IBS-C), IBS with Diarrhoea (IBS-D), mixed type IBS (IBS-M) or unsubtyped IBS (IBS-U)].
- The abdominal pain should be present for at least 1 day per week for the last 3 months and the origin of the symptoms should be at least 6 months before. The symptoms should be related to at least two of the following:
o Related to defaecation;
o Associated with a change in stool frequency;
o Associated with a change in stool (appearance);
- Able and willing to comply with all study procedures.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of gastric, small bowel or colonic surgery;
- Diagnosis of Inflammatory Bowel Disease (IBD) such as Ulcerative Colitis or Crohn’s
Disease;
- Known Coeliac Disease;
- Diagnosis of Cancer (not in remission);
- Pregnant, Breastfeeding, or trying to conceive (both women and men);
- History of suicide attempt;
- History of schizophrenia;
- History of seizures or epilepsy;
- History of drug or alcohol abuse;
- Current cannabis use (<2 months) prior to initial assessment visit;
- Severe unstable heart disease (unstable angina or ischaemic heart disease, heart failure
>NYHA Grade 2);
- Allergies to MCT oil or Cannabidiol;
- History of liver or renal disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method of allocation concealment is numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean and standard deviation data of questionnaires from all participants at
timepoints day 14 and 28, will be compared to baseline (day -7).

Statistical analysis will be performed using repeated measures (generalized) linear
mixed models. All models will include fixed effects time, group, and a group x time
interaction, as well as covariates baseline outcome score, age, sex, and concomitant
IBS medications. The model will include a random intercept for participant. Time will
be treated as linear, log-linear, quadratic, or categorical according to model fit (Akaike
information criterion). The parameter of interest will be the difference in outcome
score between treatment groups at each post-baseline study visit, adjusted for
baseline score and covariates. Where outcome variables are distributed with
excessive zeros or clustering at high or low scores, mixed effects proportional odds
models with a logit link will be used instead). Analysis of secondary outcomes will be
performed in the full sample (n = 200). A P-value of <0.05 will be deemed statistically
significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/09/2022
Actual
Date of last participant enrolment
Anticipated
1/01/2023
Actual
Date of last data collection
Anticipated
5/04/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 38179 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 311919 0
Commercial sector/Industry
Name [1] 311919 0
Schneider Von Gunn Pharmaceuticals
Country [1] 311919 0
Australia
Funding source category [2] 311920 0
Commercial sector/Industry
Name [2] 311920 0
Australian Natural Therapeutics Group
Country [2] 311920 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Schneider Von Gunn Pharmaceuticals
Address
6 Plowman Pl
Frankston Vic
3199
Country
Australia
Secondary sponsor category [1] 313410 0
None
Name [1] 313410 0
Address [1] 313410 0
Country [1] 313410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311354 0
Bellberry Limited
Ethics committee address [1] 311354 0
123 Glen Osmond Road
Eastwood SA
5063
Ethics committee country [1] 311354 0
Australia
Date submitted for ethics approval [1] 311354 0
27/10/2021
Approval date [1] 311354 0
22/02/2022
Ethics approval number [1] 311354 0
HREC2021-10-1146-A-4

Summary
Brief summary
This study is a double-blind, randomised, placebo-controlled clinical trial seeking to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS).

Given CBD’s noted anxiolytic, antidepressant, immunomodulatory, and anti-inflammatory activity, we believe that CBD will be a safe and potentially effective candidate for use in adults with IBS. Many gaps still exist in our knowledge on the efficacy and safety of cannabidiol in the clinical setting for the management of symptoms of IBS. However, with suboptimal therapeutic effects, and associated side-effects, of pharmaceutical drugs such as antidepressants, anticholinergics and opioids, this has led to this study being developed to explore CBD as a potential therapy for IBS. As such,this study will determine whether CBD may alleviate the broad list of symptoms which may present in IBS patients.
Trial website
Trial related presentations / publications
Public notes
www.svgpharma.com.au

Contacts
Principal investigator
Name 120822 0
Dr Christopher Schneider
Address 120822 0
GastroX
6 Plowman Pl
Frankston VIC
3199
Country 120822 0
Australia
Phone 120822 0
+61 414178656
Fax 120822 0
Email 120822 0
drchris@gastrox.com.au
Contact person for public queries
Name 120823 0
Mr Richard Palesh
Address 120823 0
GastroX
6 Plowman Pl
Frankston VIC
3199
Country 120823 0
Australia
Phone 120823 0
+61 483807464
Fax 120823 0
Email 120823 0
rick@svgpharma.com.au
Contact person for scientific queries
Name 120824 0
Dr Christopher Schneider
Address 120824 0
GastroX
6 Plowman Pl
Frankston VIC
3199
Country 120824 0
Australia
Phone 120824 0
+61 414178656
Fax 120824 0
Email 120824 0
drchris@gastrox.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are commercial sensitivities informing this decision.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.