Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia

NCT02660372 | Completed Phase 3

• 1 other identifier: CO-150121160547-DHCT
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Aggregate symptom score calculated from subjects assessment of 10 individual upper gastrointestinal symptoms 8 weeks after start of treatments

  Specific questionnaire with a 4 point scale

  8 weeks

Study Arms (2)

Imonogas

EXPERIMENTAL

Imonogas 120 mg, 1 capsule three times daily for 8 weeks

Drug: Imonogas

Espumisan

ACTIVE COMPARATOR

Espumisan 40 mg, 2 capsules four times daily for 8 weeks

Drug: Espumisan

Interventions

Imonogas DRUG

Simethicone 120 mg in gel capsules

Also known as: Imogas

Imonogas

Espumisan DRUG

Simethicone 40 mg in gel capsules

Espumisan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have a Body Mass Index (BMI) between 18.5-30.
• 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.
• Negative Helicobacter Pylori urea breath test.
• 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.
• Females of childbearing potential must have a negative urine pregnancy test at the baseline visit.
• 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.
• Able to read and understand the local language;
• Provide a signed and dated informed consent form prior to any study-related procedures;
• Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

City Polyclinic #2 of Moscow Health Department

Moscow, 117556, Russia

Location

MeSH Terms

Interventions

Espumisan

Study Officials

• Elisabeth Kruse

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 21, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

RU (1)