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PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms

Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acid-related Symptoms

Intervention: Esomeprazole: Nexium® 20mg, Astra Zeneca (Drug); CYP2C19 phenotypical analysis (Other); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Geneva

Overall contact:
Jules Desmeules, Pr, Phone: 41(0)22 23 05 53 87, Email: jules.desmeules@hcuge.ch

Summary

Objectives: To compare the prevalence of clinical symptoms of stomach problems between patients with progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden discontinuation of esomeprazole 40mg. The presence of clinical symptoms, as reported in the modified-Proton Pump Inhibitor Acid Suppression Symptom Test (PASS) test will be weekly assessed until 4 weeks after the inclusion. Study design: This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since 4 weeks or more, randomized to 1 week of placebo or one week of esomeprazole 20mg. The first day of the study (Day 0), three blood samples will be collected at fast to measure chromogranine A (CgA), gastrinemia, and Helicobacter Pilory (HP) serology. Cytochrome P450 (CYP)2C19 activity will be assessed. Then, at Day 1, the patients will receive esomeprazole 20mg or placebo for 7 days (Day1-8). Participants will complete the PASS test once a week on the same weekday throughout the study (Day8-D15-D22-D29), during a telephone interview or a consultation, if it was scheduled in the clinical follow up of the study. Duration of treatment: Esomeprazole or placebo for one week (Day1-8) Omeprazole single dose (Day0) Time plan of research Duration for the patient: The treatments will stop after 7 days. The questionnaires will be collected until the 4th week, Day29. Overall duration of inclusion: one year Maximal overall duration of the study: 365 days+29 days=394 days Maximal delay for communication of the results: 2 years

Clinical Details

Official title: Study of the Effect of PROGRESSive Withdrawal Esomeprazole of on Acid-related Symptoms, PROGRESS Study A Randomized, Placebo-controlled, Double Blinded Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Presence of one Clinical symptom of acid rebound

Secondary outcome:

The intensity of the acid rebound symptoms

The intensity of the acid rebound symptoms

The intensity of the acid rebound symptoms

Detailed description: ** Objectives Primary objective: To compare the prevalence of clinical symptoms of acid rebound, between patients with progressive or sudden discontinuation of Proton pump inhibitors. The presence of clinical symptoms, as described in the first question of the Proton Pump Inhibitor Acid Suppression Symptom Test will be the primary end-point, assessed at 4 weeks the inclusion. Secondary objective: To compare the prevalence of clinical symptoms of acid rebound between patients with progressive or sudden discontinuation of Proton pump inhibitors at 1,2 and 3 weeks. To compare the consequences of the clinical symptoms using the modified-Proton Pump Inhibitor Acid Suppression Symptom Test between patients with progressive or sudden discontinuation of Proton pump inhibitors at 1,2,3 and 4 weeks. To evaluate the relationship between P-gastrin, Chromogranine A, Helicobacter pilory and the clinical symptom scores. **Study design Overall description: This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since almost 4 weeks, for who its withdrawal has been decided randomized to 1 week of placebo or 1 week of esomeprazole 20mg. Patients will be recruited during their hospitalization at the time their clinician decides to withdraw esomeprazole. A first interview with the clinician will take place to inform the patient of the protocol, the day of this clinical decision. A written information will be given and another interview will take place the same day for the inclusion in the case of agreement. Then, the first day of the study (Day0), three blood samples will be collected at fast to measure Chromogranine A, gastrinemia, and Helicobacter Pilory serology. Then, the patient will receive an only dose of 40mg (CYP2C19 activity) in order to assess the CYP2C19 activity by a capillary concentration two hours later. Then, at Day1, the patients will receive esomeprazole 20mg or placebo for 7 days (Day1-8). Participants will complete the modified-Proton Pump Inhibitor Acid Suppression Symptom Test once a week on the same weekday throughout the study (Day8-15-22-29), during a telephone interview or a consultation, if it was scheduled in the clinical follow up of the study. **Primary and secondary end-points Primary outcome: The clinical significance of the rebound acid symptoms is defined by the presence of almost one of these clinical symptoms. 1. Stomach pain or discomfort, 2. Heartburn (a burning feeling rising from the stomach or lower chest towards the neck or burning feeling located behind the breastbone which may or may not rise in the chest) ; 3. Sour taste in mouth/acid regurgitation (feeling of regurgitation or unpleasant feeling moving upwards to the mouth) ; 4. Excessive burping/belching (passing of gas through the mouth) ; 5. Increased abdominal bloating (feeling of abdominal distension or fullness) ; 6. Nausea (the sensation of needing to vomit) ; 7. Early satiety (feeling full just after eating or not able to finish meals)" These symptoms are described in the Proton Pump Inhibitor Acid Suppression Symptom Test, initially deigned to assess the resolution of gastroesophageal reflux disease-symptoms following the introduction of Proton Pump Inhibitors. This test will be slightly modified to measure the outcome of the study. Secondary outcome measure:

- The consequence of the Rebound acid symptoms, using the questions of the Proton Pump

Inhibitor Acid Suppression Symptom Test test according to the presence of clinical symptoms

- CYP2C19 activity

- Gastrin and Chromogranin A.

- Helicobacter pilory serology

- Study population

Inclusion criteria: Treatment by esomeprazole 40mg since 4 weeks or more. Esomeprazole withdrawal decided by the clinician. Male and female aged over 18 years Volunteers to participate to the study Must understand and read French language Must be able to give a written informed consent. Non-inclusion criteria: Impairment of cognitive status Current indication to continue Proton pump inhibitor treatment:

- history of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison

syndrome

- Short-term treatment of documented ulcer disease, as part of a combination regimen for

Helicobacter pylori eradication

- Prevention of ulcers due to non-steroidal anti-inflammatory drugs. Hepatic impairment

(TP<60%) Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole Current pregnancy or current breastfeeding Withdrawal criteria: The different procedures for withdrawal from the study are: For patients randomized

- Discontinuation of the study due to intolerance or adverse drug reactions. For all

patients

- Evidence of active gastrointestinal bleeding after inclusion in the study;

- Right of withdrawal from the study without justification;

Patient lost of follow-up will be considered as having had clinical symptoms of acid rebound. **Selection and recruitment procedures

- Identification of eligible patients, hospitalized in the Service de medicine interne et

de réhabilitation or in the Clinique romande de réhabilitation : Only patients who received 40 mg / d. esomeprazole PO and for who the withdrawal of Proton pump inhibitor has been decided by the clinician, will be considered.

- Oral Presentation of the study and written information the day when the withdrawal is

decided. Verification of inclusion and non-inclusion criteria.

- Signature of Consent and inclusion at least 5 hours after the first information, if the

patient agrees to participate.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Treatment by esomeprazole 40mg since 4 weeks or more

- Esomeprazole withdrawal decided by the clinician

- Male and female aged 18-90 years

- Volunteers to participate to the study

- Must understand and read French language

- Must be able to give a written informed consent

Exclusion Criteria:

- Impairment of cognitive status

- Current indication to continue PPI treatment

- History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison

syndrome

- Short-term treatment of documented ulcer disease, as part of a combination regimen

for Helicobacter pylori (HP) eradication

- Prevention of ulcers due to non-steroidal anti-inflammatory drugs.

- Hepatic impairment (TP<60%)

- Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole

- Current pregnancy or current breastfeeding

Locations and Contacts

Jules Desmeules, Pr, Phone: 41(0)22 23 05 53 87, Email: jules.desmeules@hcuge.ch

Service de de médecine interne et de rehabilitation, Beau-séjour, HUG, Genève, Switzerland; Recruiting
Jules Desmeules, Pr, Phone: 41(0)22 23 05 53 87
Jules Desmeules, Pr, Principal Investigator

Service de réadaptation de l'appareil locomoteur Clinique romande de réadaptation, Sion, Sion, Switzerland; Recruiting
Lucien Roulet, Pharm D, Email: lucien.roulet@hopitalvs.ch

Additional Information

Starting date: June 2015
Last updated: June 18, 2015

Page last updated: August 23, 2015

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