Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
92
Countries
1
Sites
1
Functional Dyspepsia
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
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
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 4 Jun 2025 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
Conditions and MedDRA coding
Functional Dyspepsia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10064536 | Functional dyspepsia | 10017947 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period The monitoring period lasts from 8 up to 9 days and the treatment period is 7 days.
|
Randomised Controlled | Double | [{"id":68579,"code":2,"name":"Investigator"},{"id":68578,"code":1,"name":"Subject"}] | Group 1: ΑLKACITRAT® Group 2: PLACEBO |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients with symptoms of functional indigestion will be included if all of the following inclusion criteria apply: 1. Women or men aged 18-75 years old. 2. Patients that meet the Rome IV criteria of functional dyspepsia. 3. Patients with a GOS score≥4. 4. Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
Exclusion criteria 1
- Exclusion criteria Patients will be excluded if any of the following exclusion criteria apply: 1. Pregnant and lactating women 2. Patients with symptoms of irritable bowel syndrome and gastroesophageal reflux disease. 3. Patients with suspected symptoms of severe disease (weight loss, black stools, difficulty in swallowing). 4. Abdominal surgery. 5. Unregulated diabetes. 6. Stool disorders (chronic diarrhea or constipation). 7. Active psychiatric conditions 8. Intake of immunosuppressants, antibiotics, non-steroidal, anti-inflammatory drugs or probiotics in the last 4 weeks 9. Taking oral antacid medications that act as proton pump inhibitors, prokinetic agents, histamine receptor antagonists, and laxatives during the study 10. Patients that daily use aspirin 11. Alcohol use of more than ten units (units) per week 12. Active H. pylori infection 13. Participation in another study of an investigational medicinal product or investigational medical device
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
Secondary endpoints 5
- Comparison of the percentage of patients who responded to treatment (GOS score ≤2 at visit V1) between treatment groups
- Comparison of the change in patients' quality of life based on the NDI-SF index at visit V1 versus baseline visit (V0) between the two treatment groups.
- Comparison of the change in severity of each symptom (VAS scale) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
- Comparison of the percentage of patients in whom there was a decrease in GOS scale score of at least one point at visit V1 compared to the baseline visit (V0) between the two treatment groups.
- Frequency and type of adverse events during the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ALKACITRAT Αναβράζον δισκίο 2 g/tab
PRD5567757 · Product
- Active substance
- Betaine Citrate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 6 g gram(s)
- Max total dose
- 42 g gram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- A16AA06 — BETAINE
- Marketing authorisation
- 89058/10.10.2017
- 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
- Kifissia
- 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 SA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruiting | 92 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University General Hospital Of Thessaloniki Ahepa
1st Propaedeutic Pathology Clinic of the University General Hospital of Thessaloniki AHEPA, 1st St Kiriakidis Str, 546 36, Thessaloniki
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 | 2025-06-04 | 2025-07-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-22 | Greece | Acceptable 2024-07-08
|
2024-07-15 |