DyspepsiaPhase 4NCT03119766
Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
A Phase 4 study testing Kolofort in people with Dyspepsia, run by Materia Medica Holding at 32 sites in Russia.
Trial summary
Purpose of the study: To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Kolofort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 32 sitesRussia
- Study dates
- 28 Jun 2017to 11 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders aged 18-45 years old.
- Diagnosis of functional dyspepsia established according to Rome-IV criteria (2016).
- Severity of symptoms of dyspepsia ≥ 6 on the GIS scale.
- Negative test result for H. pylori infection .
- Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
- Patients who gave their consent to use reliable contraception during the study
Who cannot join
- Organic diseases of the gastrointestinal tract (gastroesophageal reflux disease (GERD), peptic ulcer, chronic pancreatitis, cholelithiasis, hepatosis, hepatitis, hepatic cirrhosis, etc.)
- Verified diagnosis of other functional GI diseases, i.e. biliary dyskinesia, irritable bowel syndrome, etc.
- Discontinuation of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations less than 7 days before randomization.
- H. pylori eradication within 2 months prior to enrollment.
- Intestinal infection within 2 months prior to enrollment.
- History/suspicion of oncology of any location.
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- Previously diagnosed cardiovascular diseases with functional class IV (according to the classification of the New-York Heart Association, 1964), hypothyroidism, diabetes mellitus, chronic renal disease С3-5, hepatic diseases with portal hypertension and/or signs of severe decompensation of function (> 6 points according to the Child-Pugh classification).
- Any other severe comorbidity that, in the opinion of the investigator, may affect patient participation in the clinical trial.
- Allergy/intolerance intolerances to any of the components of the study drugs.
- Pregnancy, breast-feeding.
- Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.
- Scheduled hospitalization during the study for any diagnostic or therapeutic procedures.
- Use of drugs or alcohol (more than 2 alcohol units daily), presence of mental diseases.
- Use of any medications specified in the "Prohibited Concomitant Treatment" within 1 month prior to inclusion in the study.
- Participation in other clinical trials in the previous 3 months.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Russia32 sites
South Ural State University
Chelyabinsk, 454092
Ivanovo Clinical Hospital named after Kuvaev
Ivanovo, 153025
State budget institution of health care of the Moscow region "Krasnogorsk city hospital №1"
Krasnogorsk, 143408
The State Budgetary Healthcare Institution of Moscow The Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
Moscow, 111123
Federal State Budgetary Institution Federal Research and Clinical Center for Specialized Medical Assistance and Medical Technologies of the Federal Medical Biological Agency of Russia
Moscow, 115682
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation
Moscow, 119991
The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation
Moscow, 119992
National Medical Research Center for Rehabilitation and Health Resort
Moscow, 121099
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 51 of the Moscow City Health Department"
Moscow, 121309
Federal State Budgetary Educational Institution of the Higher Education "A.I. Yevdokimov Moscow State University of Medicine and Dentistry" of the Ministry of Healthcare of the Russian Federation
Moscow, 127473
Federal State Budgetary Institution "Polyclinic No. 3" of the Administration of the President of the Russian Federation
Moscow, 129090
Private Healthcare Institution "The Road Clinical Hospital at the Nizhny Novgorod station of the open joint-stock company" Russian Railways "
Nizhny Novgorod, 603140
Novosibirsk State Medical University
Novosibirsk, 630091
State budgetary healthcare institution of the Moscow region "Podolsk City Clinical Hospital No. 3"
Podol’sk, 142105
State Autonomous Healthcare Institution of the Moscow Region "Central City Clinical Hospital in Reutov"
Reutov, 143964
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic №38"
Saint Petersburg, 191015
State budget institution of higher education "North-Western State Medical University named after I.I Mechnikov" under the Ministry of Public Health of the Russian Federation
Saint Petersburg, 191015
City Mariinsky Hospital
Saint Petersburg, 194014
Federal state budget military educational institution of higher professional education "Military Medical Academy named after S.Kirov" of the Ministry of Defense of the Russian Federation
Saint Petersburg, 194044
St. Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
Saint Petersburg, 195257
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 26"
Saint Petersburg, 196247
Limited Liability Company Gastroenterologichesky Center Expert
Saint Petersburg, 197110
Samara City Hospital #4
Samara, 443056
LLC Medical company "Hepatologist"
Samara, 443063
Saratov State Medical University named after V. I. Razumovsky
Saratov, 410054
Saratov City Clinical Hospital #5
Saratov, 410071
St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"
Sestroretsk, 197706
Stavropol Regional Clinical Consultative and Diagnostic Center
Stavropol, 355017
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063
State Autonomous Healthcare Institution of the Yaroslavl Region "N.V. Clinical Emergency Hospital Solovyov "
Yaroslavl, 150003
Municipal Budgetary Institution "Central City Hospital No. 7"
Yekaterinburg, 620137
About this study
Official title: Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia
Purpose of the study:
To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
Read the detailed description
Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).
At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed.
On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires.
The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination of the patient is performed. The investigator monitors the prescribed and concomitant therapy, evaluates the safety of therapy and the degree of adherence to treatment (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects complaints, registers the physical examination data, monitors the prescribed and concomitant therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are filled in.
Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out the Clinical Global Impression-Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Prohibited Concomitant Treatment".
- Conditions
- Dyspepsia
- Being tested
- Kolofort, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KolofortDrug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Kolofort | Experimental | Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. Receives: Drug: Kolofort |
| Placebo | Placebo comparator | Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Severity of Functional Dyspepsia Symptoms
Changes in severity of functional dyspepsia symptoms due to GIS score (Gastrointestinal symptom score) at week 8 from the start of study therapy. The GIS scale includes 10 subscales (symptoms), the severity of each one was evaluated from 0 to 4 points (by Lickert scale).For example, the absence of the mentioned symptom is classified as "0". The most severe is classified as "4".
The all 10 subscales were combined to compute a total score. So the total range is a sum of all subscales.The total score is in range from 0 till 40. So the minimum value is 0, the maximum is 40.
Measured: On baseline, after 4 and 8 weeks of the treatment
Secondary outcomes (5)
Percentage of Patients With a Decrease in the Severity of FD Symptoms
Percentage of patients with a decrease in the severity of FD symptoms on the GIS scale after 8 weeks from the start of study therapy. The GIS scale is composed of 10 points evaluating the extent of manifestation of a wide range of gastroenterological symptoms. The intensity of clinical symptoms will be evaluated based on a 5-point Likert scale from 0 to 4 where 0 = no, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe).
Measured: After 8 weeks of the treatment
Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index)
Change in the severity of the functional dyspepsia index NDI (Nepean dyspepsia index) after 8 weeks from the start of the study therapy. The NDI questionnaire involves the patient's self-assessment of various manifestations of the disease and how much FD affects his life. The range of possible fluctuations in the total score of the Nepean dyspepsia index is from 10 to 50.
The scale consists of 10 questions. Each section corresponds to 5 answer options (the lower score is 1, the highest is 5), reflecting the gradation of the severity of the symptom and coded according to the increase in the severity of the symptom or the loss of the ability to perform a certain task in the framework of daily activities. The minimum value is 10, the maximum value is 50. The higher score represents the worst outcome.
Measured: On baseline, after 4 and 8 weeks of the treatment
Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale
The scale reflects the general well-being of a person, which is affected by the state of health, and consists of 11 questions. In the composition of the SF-36 dedicated 8 sections:1. Physical functioning,2. Role (physical) functioning 3. Pain.4. General health.5. Vitality.6. Social functioning.7. Emotional functioning. 8. Psychological health.The sections of the scale are combined into 2 total dimensions - the physical component of health (1-4 questions) and mental (5-8 questions). Subscales (questions 1-4) were summed to provide the information about the physical component, subscales (questions 5-8) - about the mental component. Each scale ranges from 0 to 100 so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Measured: On baseline and after 8 weeks of the treatment
Percentage of Patients Terminating the Study Early
Percentage of patients terminating the study early due to lack of efficacy of the study therapy. Lack of efficacy of the study therapy is defined as retention or progression of the symptoms of functional dyspepsia resulting in prescription of the products for FD therapy (proton pump inhibitors, prokinetics, spasmolytics).
Measured: in 8 weeks of the treatment
Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale
Indicators of therapeutic and side effects, efficacy index on the scale of the general clinical impression CGI-EI (Clinical Global Impression Scale - Efficacy Index) after 8 weeks from the start of study therapy. Clinical Global Impression Efficacy Index (CGI-EI) will be filled by the investigator at the final Visit 5 (Week 8±3 days). Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects value from 1 to 4. Therapeutic effect value as 0,4,8 or 12 points. The efficacy index is a sum. The minimum value is 1, the maximum value is 16. A lower score on the scales is the best outcome.
Measured: After 8 weeks of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start28 Jun 2017
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119766
- Sponsor's protocol ID
- MMH-KOL-003
- Status last verified
- Jun 2019
- First submitted
- 4 Apr 2017
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03119766
- Acronym / sponsor ID
- MMH-KOL-003
- Conditions
- Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study:
To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
Detailed description
Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).
At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed.
On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires.
The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination of the patient is performed. The investigator monitors the prescribed and concomitant therapy, evaluates the safety of therapy and the degree of adherence to treatment (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects complaints, registers the physical examination data, monitors the prescribed and concomitant therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are filled in.
Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out the Clinical Global Impression-Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Prohibited Concomitant Treatment".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kolofort | Experimental | Drug: KolofortTablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. |
| Placebo | Placebo comparator | Drug: PlaceboTablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of both genders aged 18-45 years old.
- Diagnosis of functional dyspepsia established according to Rome-IV criteria (2016).
- Severity of symptoms of dyspepsia ≥ 6 on the GIS scale.
- Negative test result for H. pylori infection .
- Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
Key exclusion criteria (17 listed)
- Organic diseases of the gastrointestinal tract (gastroesophageal reflux disease (GERD), peptic ulcer, chronic pancreatitis, cholelithiasis, hepatosis, hepatitis, hepatic cirrhosis, etc.)
- Verified diagnosis of other functional GI diseases, i.e. biliary dyskinesia, irritable bowel syndrome, etc.
- Discontinuation of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations less than 7 days before randomization.
- H. pylori eradication within 2 months prior to enrollment.
- Intestinal infection within 2 months prior to enrollment.
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 |
|---|---|---|
| KolofortOral administration | Drug | Kolofort |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Changes in Severity of Functional Dyspepsia Symptoms
Time frame: On baseline, after 4 and 8 weeks of the treatment
Changes in severity of functional dyspepsia symptoms due to GIS score (Gastrointestinal symptom score) at week 8 from the start of study therapy. The GIS scale includes 10 subscales (symptoms), the severity of each one was evaluated from 0 to 4 points (by Lickert scale).For example, the absence of the mentioned symptom is classified as "0". The most severe is classified as "4". The all 10 subscales were combined to compute a total score. So the total range is a sum of all subscales.The total score is in range from 0 till 40. So the minimum value is 0, the maximum is 40.
5 secondary outcomes
Percentage of Patients With a Decrease in the Severity of FD Symptoms
Time frame: After 8 weeks of the treatment
Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index)
Time frame: On baseline, after 4 and 8 weeks of the treatment
Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale
Time frame: On baseline and after 8 weeks of the treatment
Percentage of Patients Terminating the Study Early
Time frame: in 8 weeks of the treatment
Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale
Time frame: After 8 weeks of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kolofort in people with Dyspepsia, run by Materia Medica Holding at 32 sites 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 6 inclusion and 17 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Severity of Functional Dyspepsia Symptoms (time frame: On baseline, after 4 and 8 weeks of the treatment). 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 7 Jun 2022.