Clinical trial • Not applicable • Gastroenterology
Citalopram for Gastroesophageal reflux disease | Reflux hypersensitivity | Functional heartburn
Not applicable trial of Citalopram for Gastroesophageal reflux disease | Reflux hypersensitivity | Functional heartburn.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Gastroesophageal reflux disease | Reflux hypersensitivity | Functional heartburn
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 23-10-2024
Trial design
Placebo tablet manufactured by Laboratoria Wolfs, Zwijndrecht (oral tablet; ingredients listed in product description). Active investigational product: Citalopram Viatris 20 mg filmomhulde (film-coated) tablets; add-on treatment of citalopram 20 mg for 8 weeks (as stated in main objective).-controlled Not applicable trial across 3 sites in Belgium.
- Comparator
- Placebo tablet manufactured by Laboratoria Wolfs, Zwijndrecht (oral tablet; ingredients listed in product description). Active investigational product: Citalopram Viatris 20 mg filmomhulde (film-coated) tablets; add-on treatment of citalopram 20 mg for 8 weeks (as stated in main objective).
- Target Sample Size
- 100
- Trial Duration For Participant
- 56
Eligibility
Recruits 100 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults aged 18 to 65 years and must be capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. Subject information sheets and informed consent forms are provided (languages include French and Dutch as indicated by available L1_SIS and ICF_FR and L1_SIS and ICF_NL documents)..
- Pregnancy Exclusion
- Pregnancy or breast feeding.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults aged 18 to 65 years and must be capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. Subject information sheets and informed consent forms are provided (languages include French and Dutch as indicated by available L1_SIS and ICF_FR and L1_SIS and ICF_NL documents).
Inclusion criteria
- {"criterion_text":"-18 to 65 years old.\n-History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.\n-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).\n-pH-impedance values: AET ≤4% and ≤80 reflux episodes on the first 24h pH-impedance measurement\n-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.\n-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
- {"criterion_text":"-Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.\n-Pregnancy or breast feeding.\n-History of poor compliance.\n-History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.\n-History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.\n-Systemic diseases, known to affect esophageal motility.\n-Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).\n-QTc >450 ms\n-Treatment with SSRI’s prior to the start of the study.\n-Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics or medications that increase the risk of a serotoninergic syndrome\n-Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.\n-Major psychiatric disorder.\n-Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Change in number of reflux episodes","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"-Change in volume exposure of reflux\n-Change in number of reflux episodes with a high proximal extent\n-Change in esophageal sensitivity\n-Change in symptom severity\n-Predictive value of reflux assessment, assessment of esophageal sensitivity and reflux questionnaire","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 103
- Consent Approach
- Informed consent is provided by the participants themselves; subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures. Subject information sheets and informed consent forms are available in French and Dutch (documents: L1_SIS and ICF_FR_2024-517019-57 and L1_SIS and ICF_NL_2024-517019-57). No assent process for minors is indicated because the study population is 18 to 65 years old.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 100
Belgium
- Latest Decision Or Authorization Date
- 23-10-2024
- Number Of Sites
- 3
- Number Of Participants
- 100
Sites
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Jan Tack
- Principal Investigator Email
- jan.tack@kuleuven.be
- Contact Person Name
- Jan Tack
- Contact Person Email
- jan.tack@kuleuven.be
- Site Name
- UZ Brussel
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Sebastien Kindt
- Principal Investigator Email
- sebastien.kindt@uzbrussel.be
- Contact Person Name
- Sebastien Kindt
- Contact Person Email
- sebastien.kindt@uzbrussel.be
- Site Name
- Antwerp University Hospital
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Heiko De Schepper
- Principal Investigator Email
- heiko.deschepper@uza.be
- Contact Person Name
- Heiko De Schepper
- Contact Person Email
- heiko.deschepper@uza.be
Sponsor
Primary sponsor
- Full Name
- UZ Leuven
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Citalopram Viatris 20 mg filmomhulde tabletten
- Active Substance
- Citalopram
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Marketing authorisation BE242541 (authorised product information present)
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Maximum Dose
- 20 mg
- Investigational Product Name
- Placebo tablet manufactured by Laboratoria Wolfs, Zwijndrecht.
- Modality
- Other
- Routes Of Administration
- Oral (tablet)
- Route
- Oral
- Authorisation Status
- Not applicable (placebo; no active substance marketing authorisation)
- Combination Treatment
- Yes
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