Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
obesity
To evaluate the effect of PPI’s on the structural integrity of the ESG
Key facts
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Feb 2024 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517679-18-00
- EudraCT number
- 2021-000266-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the effect of PPI’s on the structural integrity of the ESG
Secondary objectives 1
- effects of ESG on weight loss, quality of life, metabolic risk factors and anthropometry and on satiety.
Conditions and MedDRA coding
obesity
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol
Exclusion criteria 19
- Active gastric gastro-duodenal during the last 6 months
- Helicobacter pylori infection
- Organic or motility disorder of the stomach and / or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- Ongoing or active malignancy during the last 5 years
- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification
- Drug or alcohol abuse
- Bulimic or binge eating pattern
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease
- Pregnancy, breastfeeding
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- Hiatal hernia ≥ 5 cm
- Known allergy or hypersensitivity to the active substance or any of the other excipients
- Liver cirrhosis of any Child-Phugh stage or MELD> 15
- Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
- Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the assess the effect of PPIs on the proportion of patients with “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up
Secondary endpoints 1
- to assess the effect of PPI on the proportion of patients with “intact ESG”, “partially intact ESG” and “open ESG”, separately, at 12 months of follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB01960MIG · Substance
- Active substance
- Esomeprazole
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01960MIG · Substance
- Active substance
- Esomeprazole
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Address
- Largo Francesco Vito 1
- City
- Rome
- Postcode
- 00168
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Ivo Boskoski
Public contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Ivo Boskoski
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 40 | 1 |
| 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 |
|---|---|---|---|---|---|
| Italy | 2024-02-09 | 2024-02-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT Number 2024-517679-18-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consenso trattamento dati | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Esomeprazole | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_EU CT Number 2024-517679-18-00 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Italy | Acceptable 2024-10-29
|
2024-12-02 |