Functional DyspepsiaPhase 3NCT02660372
Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia
A Phase 3 study testing Imonogas and Espumisan in people with Functional Dyspepsia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Russia.
Trial summary
The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Imonogas and Espumisan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.
Read the detailed 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.
- Conditions
- Functional Dyspepsia
- Being tested
- Imonogas, Espumisan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImonogasDrug
Also called Imogas
Simethicone 120 mg in gel capsules
EspumisanDrug
Simethicone 40 mg in gel capsules
| Study group | Role | What they receive |
|---|---|---|
| Imonogas | Experimental | Imonogas 120 mg, 1 capsule three times daily for 8 weeks Receives: Drug: Imonogas |
| Espumisan | Active comparator | Espumisan 40 mg, 2 capsules four times daily for 8 weeks Receives: Drug: Espumisan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660372
- Sponsor's protocol ID
- CO-150121160547-DHCT
- Status last verified
- Dec 2016
- First submitted
- 11 Jan 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02660372
- Acronym / sponsor ID
- CO-150121160547-DHCT
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imonogas | Experimental | Drug: ImonogasImonogas 120 mg, 1 capsule three times daily for 8 weeks |
| Espumisan | Active comparator | Drug: EspumisanEspumisan 40 mg, 2 capsules four times daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImonogasAlso: ImogasSimethicone 120 mg in gel capsules | Drug | Imonogas |
| EspumisanSimethicone 40 mg in gel capsules | Drug | Espumisan |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Functional Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imonogas and Espumisan in people with Functional Dyspepsia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate symptom score calculated from subjects assessment of 10 individual upper gastrointestinal symptoms 8 weeks after start of treatments (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.