Overview
Sponsor-declared trial summary
Second line treatment for colonoscopy preparation
The aim of the study is to evaluate the efficacy of the combination of CLINITRAT and PICOPREP medicinal products in bowel preparation before colonoscopy in patients with inadequate preparation at reference colonoscopy.
Key facts
- Sponsor
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 10 Nov 2025 → ongoing
- Decision date (initial)
- 2025-07-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others
The aim of the study is to evaluate the efficacy of the combination of CLINITRAT and PICOPREP medicinal products in bowel preparation before colonoscopy in patients with inadequate preparation at reference colonoscopy.
Secondary objectives 1
- Patient tolerance which will be assessed on the basis of a questionnaire
Conditions and MedDRA coding
Second line treatment for colonoscopy preparation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10066943 | Bowel preparation | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period The treatment period will last up to 2 days. The follow-up visit will be 2 weeks after the initial visit and no later than 12 weeks after V0 (initial visit).
|
Randomised Controlled | Double | [{"id":134648,"code":1,"name":"Subject"},{"id":134647,"code":2,"name":"Investigator"}] | Group 1: CLINITRAT® Group 2: PLACEBO |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Women and/or men at least 18 years old
- Women and/or men with inadequate preparation on reference colonoscopy, score <6 points according to the Boston Bowel Preparation Scale (BBPS)
- Patients who are legally competent and capable of understanding the information provided about the study, have been informed about the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
Exclusion criteria 20
- Common contraindications for colonoscopy (suspected perforation, toxic megacolon, pyloric stenosis, severe colitis, pregnancy, lactation)
- Allergy or hypersensitivity to study drugs
- Non-compliance with instructions for bowel preparation during reference colonoscopy (receiving <75% of bowel preparation)
- Polyposis syndrome and refusal to participate in the study
- Pregnancy
- Lactation
- Participation in another study of an investigational medicinal product or investigational medical device
- Severe heart failure (NYHA III/IV)
- Severe chronic kidney disease (eGFR<30)
- Type I diabetes
- Patients with colon segmental resection
- Patients suffering from severe dehydration
- Rhabdomyolysis
- Hypermagnesemia
- Patients suffering from active inflammatory bowel disease
- Intestinal obstruction or perforation
- Ileus, gastric retention, acute intestinal or gastric ulceration
- Acute abdominal conditions requiring immediate surgery, such as acute appendicitis
- Nausea and vomiting
- Toxic megacolon
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.
Secondary endpoints 5
- Average BBPS total score
- Partial BBPS sub-score for the right (ascending) colon
- Polyp detection rate
- Percentage of colonoscopies reaching the cecum
- Patient tolerance, which will be assessed based on a questionnaire assessing the tolerance of the preparation translated and updated in Greek
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CLINITRAT® (6.563+175,4+89,3+23,3) mg/sachet ή stick, Κόνις για πόσιμο διάλυμα
PRD5078570 · Product
- Active substance
- Sodium Hydrogen Carbonate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 41.4 g gram(s)
- Max total dose
- 82.8 g gram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- A06AD65 — MACROGOL, COMBINATIONS
- Marketing authorisation
- 3109301
- MA holder
- UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Sponsor organisation
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Address
- Building A And B, 14th Km Athina Lamia National Road 1 14th Km Athina Lamia National Road 1
- City
- Kifisia
- Postcode
- 145 64
- Country
- Greece
Scientific contact point
- Organisation
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Contact name
- Georgios-Stefanos Soumelas
Public contact point
- Organisation
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Contact name
- Uni-Pharma S.A.
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruiting | 188 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Greece | 2025-11-10 | 2025-11-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PICO_TRAT_final protocol | 1.1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_CLINITRAT | 2 |
| Synopsis of the protocol (for publication) | PICOTRAT_protocol synopsis | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-31 | Greece | No conclusion 2025-07-14
|
2025-07-18 |