Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
48
Countries
1
Sites
1
Achalasia
To investigate the effect of citalopram, as compared to a placebo, on spontaneous chest pain episodes in patients with achalasia.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- completed 19 Feb 2026
- Decision date (initial)
- 2024-12-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517701-81-01
- EudraCT number
- 2019-001202-14
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To investigate the effect of citalopram, as compared to a placebo, on spontaneous chest pain episodes in patients with achalasia.
Secondary objectives 3
- To compare chest pain frequency, intensity and duration after treatment with citalopram or placebo
- To assess the side-effects of the treatment with citalopram
- To evaluate the effect of treatment with citalopram or placebo on the health status, psychological state and anxiety of the patient.
Conditions and MedDRA coding
Achalasia
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517701-81-00 | Effect of citalopram on chest pain in patients with achalasia. | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Written informed consent
- Minimum age: 18 years. Maximum age: 75 years.
- Diagnosed with achalasia type 1 or 2, confirmed by high-resolution manometry
- Previously treated with pneumodilatation, Heller’s myotomy or POEM
- ≥3 months post-treatment for achalasia
- Midline chest pain or discomfort that is not of burning quality
- At least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
- No significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
- At start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy (Date of last endoscopy cannot be longer than 5 years ago)
Exclusion criteria 11
- Achalasia type 3 (‘’spastic type’’) or spastic contractions on high-resolution manometry
- Surgery of the esophagus except Heller’s myotomy and POEM
- Currently using antidepressants
- Chest pain suspect of cardiac origin
- Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
- Pregnancy or lactation. A pregnancy test will be carried out prior to inclusion in the study. Female patients who are premenopausal and have a negative pregnancy test should be on an anticonceptive.
- Allergy to barium sulfate
- Contraindication for concomitant use of MAO-inhibitors
- Contraindication for concomitant use of drugs that prolong the QT interval: such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (such as sparfloxacin, moxifloxacin, erythromycin iv, pentaria, treatment with malaria) particular halofantrine), certain antihistamines (astemizol, mizolastine).
- Contraindication for concomitant use with moclobemide and buspiron
- Hypersensitivity to citalopram, placebo or to any of the excipients: Lactose, mannitol, microcrystalline cellulose, colloidal silica, anhydrous, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Global assessment of chest pain relief after 6 weeks of treatment with citalopram
Secondary endpoints 7
- Symptom frequency and symptom severity score (calculated from symptom diary)
- Health-related Quality of life (SF-36)
- Achalasia-specific health-related quality of life (Ach-HRQL)
- Hospital Anxiety and depression scale (HADS)
- Adverse events/ complications/ side-effects
- Patients estimation about the received treatment (‘’Which treatment did you think you’ve received?’’)
- Symptom severity and time to perception during esophageal acid perfusion and threshold balloon pressure during esophageal barostat balloon distension test (sub-study).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Citalopram CF 20 mg, filmomhulde tabletten
PRD385917 · Product
- Active substance
- Citalopram
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB04 — CITALOPRAM
- Marketing authorisation
- RVG 25148
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The study medication will be packed and labelled under GMP annex 13 by the pharmacy of the AMC.
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
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Amsterdam UMC
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Amsterdam UMC
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
Gastroenterology and Hepatology, De Boelelaan 1117, 1081 HV, Amsterdam
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_2024-517701-81-01 Protocol CiPA | 4 |
| Recruitment arrangements (for publication) | K1_Positive opinion under the CTD | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CiPA | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CiPA substudy achalasie | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CiPA substudy healthy subjects | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC citalopram 20mg | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-29 | Netherlands | Acceptable 2024-12-23
|
2024-12-23 |