Citalopram for reflux hypersensitivity and functional heartburn

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

10 Apr 2018 → ongoing

Decision date (initial)

2024-10-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517019-57-00

EudraCT number

2017-004174-34

ClinicalTrials.gov

NCT03499171

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the efficacy of citalopram 20 mg 8 weeks add-on treatment in patients with reflux hypersensitivity or functional heartburn and an incomplete response to PPI therapy

Secondary objectives 1

1. To assess the predictive value of reflux assessment, the assessment of esophageal sensitivity and questionnaire results on the primary outcome

Conditions and MedDRA coding

gastro-esophageal reflux disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 18 to 65 years old.
2. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
3. Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
4. pH-impedance values: AET ≤4% and ≤80 reflux episodes on the first 24h pH-impedance measurement
5. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
6. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Exclusion criteria 13

1. Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
2. Systemic diseases, known to affect esophageal motility.
3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
4. QTc >450 ms
5. Treatment with SSRI’s prior to the start of the study.
6. Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics or medications that increase the risk of a serotoninergic syndrome
7. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
8. Major psychiatric disorder.
9. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
10. Pregnancy or breast feeding.
11. History of poor compliance.
12. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
13. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in number of reflux episodes

Secondary endpoints 5

1. Change in volume exposure of reflux
2. Change in number of reflux episodes with a high proximal extent
3. Change in esophageal sensitivity
4. Change in symptom severity
5. Predictive value of reflux assessment, assessment of esophageal sensitivity and reflux questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

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.

Application history

1 submissions — initial application plus substantial / non-substantial modifications