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NCT02660372
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
Phase 3 trial testing Imonogas in Functional Dyspepsia in 210 participants. Completed in 1 December 2016.
1 October 2016
Quick facts
| Lead sponsor | Johnson & Johnson Consumer and Personal Products Worldwide |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 1 February 2016 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across Russia |
Drugs / interventions tested
Conditions studied
- Functional Dyspepsia — all drugs for Functional Dyspepsia →
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide — full company profile →
Who can join
18 and older, any sex, with Functional Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Aggregate symptom score calculated from subjects assessment of 10 individual upper gastrointestinal symptoms 8 weeks after start of treatments
Time frame: 8 weeks
Specific questionnaire with a 4 point scale
Sponsor's own description
The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02660372
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Functional Dyspepsia
Currently open trials in the same condition.
- NCT07442734 — Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms · NA · recruiting
- NCT07250308 — Correlation Study of Atrophic Gastritis and Dyspepsia Symptoms · recruiting
- NCT07187492 — Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
- NCT07182890 — Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
- NCT07210294 — Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia · NA · recruiting
Other Johnson & Johnson Consumer and Personal Products Worldwide trials
Trials by the same sponsor.
- NCT06798441 — Determination of the Oral Irritation Potential of a Fluoride Rinse in Children · NA · completed
- NCT06479096 — Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash · NA · completed
- NCT07028671 — Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms · completed
- NCT03213353 — A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms · Phase 1 · completed
- NCT03041064 — Multiday Beach Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02660372 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Consumer and Personal Products Worldwide
- Last refreshed: 14 December 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02660372.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing