Overview
Sponsor-declared trial summary
Obesity
To evaluate the effect of cholestyramine treatment on serum concentrations of different persistent organic pollutants in a population of obese women of childbearing age for whom bariatric surgery is indicated
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 8 Feb 2024 → ongoing
- Decision date (initial)
- 2023-06-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate the effect of cholestyramine treatment on serum concentrations of different persistent organic pollutants in a population of obese women of childbearing age for whom bariatric surgery is indicated
Secondary objectives 1
- Evaluation of the effect of pre-operative cholestyramine treatment in relation to observed and expected post-bariatric surgery release
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10014989 | Epidermolysis bullosa | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Female patients with an accepted indication for bariatric surgery (BMI > 40 kg/m2 or BMI > 35 kg/m2 with complication(s) improveable by surgery)
- Aged between 18 and 45 years
- Having effective contraception (according to Recommendations related to contraception and pregnancy testing in clinical trials Version 1.2 (CTCG Clinical Trials Coordination Group))
Exclusion criteria 6
- Pregnant or breastfeeding women
- Known allergy or intolerance to cholestyramine
- Chronic constipation
- Chronic disease that may interfere with the efficacy of treatment (unbalanced diabetes with HbA1c >7%, known and treated dyslipidaemia, chronic renal failure with GFR <60 ml/min, hepatocellular failure)
- Phenylketonuria
- Patients on anti-vitamin K, digoxin, levothyroxine or likely to be on such therapy within 3 months of inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Serum concentration of persistent organic pollutants between M0 (pre-surgery) and M4 (post-surgery)
Secondary endpoints 1
- Measurement of serum concentrations of persistants organics pollutants by mass spectrometry after bariatric surgery and determination of their evolution in relation to expected release.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
QUESTRAN 4 g, poudre orale en sachet
PRD7596346 · Product
- Active substance
- Colestyramine
- Substance synonyms
- CHOLESTYRAMINE
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- IN DRINKING WATER USE
- Max daily dose
- 12 g gram(s)
- Max total dose
- 372 g gram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AC01 — COLESTYRAMINE
- Marketing authorisation
- 34009 315 027 2 2
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Nicolas CHEVALIER
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Christine PINTARIC
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | 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 |
|---|---|---|---|---|---|
| France | 2024-02-08 | 2025-03-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PROTOCOL_2023-505116-37-00 | 3 |
| Protocol (for publication) | PROTOCOL_2023-505116-37-00_SOC | 1 |
| Recruitment arrangements (for publication) | Additionnal Document | 0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 0 |
| Subject information and informed consent form (for publication) | SIS and ICF | 0 |
| Subject information and informed consent form (for publication) | SIS and ICF_2023-505116-37-00_FP | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_cholestyramine | 1 |
| Synopsis of the protocol (for publication) | PROTOCOL SYNOPSIS_FR_2023-505116-37-00 | 3 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-14 | France | Acceptable 2023-06-13
|
2023-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-04 | France | Acceptable | 2023-08-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-18 | France | Acceptable 2025-10-30
|
2025-10-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-18 | France | Acceptable | 2025-12-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-15 | France | Acceptable 2026-02-03
|
2026-02-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-05 | France | Acceptable 2026-04-22
|
2026-04-27 |