NL-OMON27122CompletedPhase 4
Benesco TM for reflux symptoms: efficacy and mechanism of action
Amsterdam UMC, location AMC0 sites108 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 108
Study Overview
Brief Summary
One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1–21) reflux-free days were reported compared to 10 (2–25) in the placebo group (p = 0.673). In addition, 38 (34–41) versus 39 (35–42) reflux-free nights were reported (p = 0.409).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Written informed consent. - Both male and female patients will be included. - Age above 18 years. - Symptoms of heartburn and/or acid regurgitation at least 3 times a week - A total reflux symptom score =8 (measured through the GerdQ questionnaire score).
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: - Use of any medication with an effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study except antacids (e.g. proton pump inhibitors, H2-blockers, antidepressants, prokinetics). Medication must be stopped at least two weeks upon inclusion. - Less than 50% response to PPI (if previously used) - Known Barrett’s esophagus - History of gastric or esophageal surgery - Known allergy to one of the ingredients of Benesco - Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) - Pregnant, lactating or fertile women (without contraception)
Investigators
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