Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia
Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia
The aim of this study is to show non-inferiority of two brands of simeticone in adult
 patients suffering from functional dyspepsia.
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.
Inclusion Criteria:

 1. Subjects of the age of 18 years or older with a suspected diagnosis of functional
 dyspepsia according to Rome III criteria (see Appendix A) e.g. subjects suffering from
 bothersome postprandial fullness or early satiation or epigastric pain or epigastric
 burning AND no evidence of structural disease (including upper GI endoscopy) that is
 likely to explain the symptoms. Criteria fulfilled for the last 3 months. Symptom
 onset at least 6 months prior to diagnosis.

 2. Have a Body Mass Index (BMI) between 18.5-30.

 3. Absence of significant structural/organic abnormalities on abdominal ultrasound and
 upper gastrointestinal endoscopy performed within the last 3 months prior to baseline
 to exclude a structural cause for the symptoms.

 4. Negative Helicobacter Pylori urea breath test.

 5. Presence of at least three out of the assessed ten symptoms judged to be at least of
 moderate or severe intensity, assessed after withdrawal of any medication potentially
 affecting the gastrointestinal tract and at least 7 days wash-out period.

 6. Females of childbearing potential must have a negative urine pregnancy test at the
 baseline visit.

 7. Male or non-pregnant, non-lactating female agree to the contraceptive requirements
 (including female partner's use of a highly effective form of birth control for at
 least 3 months before the study, during the study and for 3 months after the last dose
 of study drug) as outlined in Section 10.7.4.

 8. Able to read and understand the local language;

 9. Provide a signed and dated informed consent form prior to any study-related
 procedures;

 10. Willing and able to comply with all study procedures and attend the scheduled visits
 for the duration of the study.

 Exclusion Criteria:

 1. Subjects meeting the diagnostic Rome III criteria for Irritable Bowel Disease (IBS)
 (see Appendix A).

 2. 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).

 3. 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.

 4. Known hepatic, biliary or pancreatic disease.

 5. Known lactose or gluten intolerance or celiac disease.

 6. Known HIV positive or AIDS.

 7. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine,
 marijuana, opiates).

 8. 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:

 -  gastrointestinal medications including antispasmodics, prokinetics, proton pump
 inhibitors, H2 blockers, antacids, alginate, bismuth preparations, sucralfate,
 misoprostol, charcoal, diosmectite, enzymes (e.g. Kreon®, Mezim®).

 -  other medications that could interfere with gastrointestinal function e.g.
 antibiotics (except for local application), theophylline, NSAIDs (except for
 low-dose aspirin for prevention of heart disease), opioid analgesics, codeine,
 ulcerogenic substances (e.g. oral glucocorticoids), anxiolytics, neuroleptics,
 antidepressants, and/or others in the judgment of the investigator.

 9. Females who are pregnant or breastfeeding.

 10. Males with a pregnant partner or a partner who is currently trying to become pregnant.

 11. Known sensitivity to the investigational products.

 12. Subjects who were previously screened and ineligible or were randomized to receive
 investigational product.

 13. Currently participating in another clinical trial or has done so in the past 30 days.

 14. 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).

 15. 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.