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Benesco for reflux symptoms: efficacy and mechanism of action

Benesco for reflux symptoms: efficacy and mechanism of action - Benesco for reflux symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54012
Enrollment
108
Registered
2020-12-17
Start date
2021-03-15
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearburn pyrosis

Interventions

During the study period of 6 weeks, patients will receive 3 times daily 200 mg of benescoTM or a placebo Patients will fill out symptom questionnaires at baseline and every week for the total durati

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria: - 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)

Design outcomes

Primary

MeasureTime frame
The primary outcome is treatment success, defined as a reduction in symptoms of 50%.

Secondary

MeasureTime frame
Secondary outcomes include reduction in symptom frequency and symptom severity (using a symptom diary).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026