Status and phase
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About
The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.
Full description
This is a multi-center, randomized, observer-blind, parallel-group, 8-weeks, non-inferiority clinical trial to compare the efficacy and safety of two brands of Simeticone for symptomatic treatment of functional dyspepsia in adults.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Subjects meeting the diagnostic Rome III criteria for Irritable Bowel Disease (IBS) (see Appendix A).
a) severe gastroesophageal reflux symptoms (typical symptoms - heartburn, regurgitation, dysphagia, odynophagia, and/or signs of reflux at upper GI endoscopy) at Screening visit.
b) predominant gastroesophageal reflux symptoms defined as a Subject's Symptom Severity Score of 2 or more for heartburn and regurgitation at Baseline visit after the 7-days wash-out period (see questionnaire in Appendix B).
Significant medical condition which may interfere with a subject's participation in the study, e.g. diabetes mellitus, thyroid dysfunction, renal insufficiency, congestive heart failure, electrolyte disturbances or autoimmune diseases requiring immunosuppressive treatment.
Known hepatic, biliary or pancreatic disease.
Known lactose or gluten intolerance or celiac disease.
Known HIV positive or AIDS.
Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates).
Unwillingness or inability to withdraw and abstain from medication which is likely to affect gastrointestinal function or symptoms during the 7-days wash-out period and throughout the study period, including the following drugs:
Females who are pregnant or breastfeeding.
Males with a pregnant partner or a partner who is currently trying to become pregnant.
Known sensitivity to the investigational products.
Subjects who were previously screened and ineligible or were randomized to receive investigational product.
Currently participating in another clinical trial or has done so in the past 30 days.
Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, subinvestigators, study coordinators, other site personnel, employees of Johnson & Johnson LLC or McNeil AB subsidiaries, contractors of Johnson & Johnson LLC or McNeil AB, and the families of each).
Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Primary purpose
Allocation
Interventional model
Masking
210 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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