- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02365701
Study of Motilitone to Treat Functional Dyspepsia
May 20, 2019 updated by: Dong-A ST Co., Ltd.
Double-blind, Placebo-controlled, Randomized, 4-week, Phase II Clinical Trial for Assessment of Efficacy and Safety of Motilitone in Patients With Functional Dyspepsia
This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in patients with Functional Dyspepsia as measured by change in maximum tolerated volume and aggregate symptom score on the nutrient drink test.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
(1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following:
- Bothersome postprandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning AND No evidence of structural disease at upper endoscopy within last 3 months that is likely to explain the symptoms These must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- (2) At least a moderate or severe level within the previous 3 months for two of the following eight symptoms: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe).
- (3) Subjects should be able to provide a written informed consent.
Exclusion Criteria:
- (1) Subject currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study.
- (2) Women of childbearing potential who are not using contraception and pregnant or lactating women.
- (3) Subject who had surgery that may affect gastrointestinal motility.
- (4) Subject with known history of gastric bleeding, intestinal obstruction or perforation.
- (5) Subject with known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis.
- (6) Subject who had any of the diseases such as reflux esophagitis, gastroduodenal ulcer, gastric adenocarcinoma, esophageal adenocarcinoma, pancreatic disease, etc. that may be an organic cause of dyspepsia.
- (7) Subject with liver dysfunction (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase is at least 2.5 times higher than ULN).
- (8) Subject with renal dysfunction (Serum creatinine level is at least 1.5 times higher than ULN).
- (9) Subject with a serious cardiovascular (including known baseline QT prolongation defined by >450 msec) or respiratory illness.
- (10) Subject with diagnosed psychotic illnesses, substance dependence or alcoholism.
- (11) Subject currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, Reglan, erythromycin, azithromycin, Domperidone, etc.), Buspirone, Acotiamide, Tramadol, nonsteroidal anti-inflammatory drug, systemic corticosteroids, and antidepressants, etc. within last 2 weeks of randomization.
- (12) Medications that can affect QT within last 2 weeks of randomization.
- (13) Subjects on herbal supplements for Functional Dyspepsia within last 2 weeks of randomization.
- (14) Subjects with gastric electric stimulator in place.
- (15) Subjects on narcotics or benzodiazepines within 7 days of randomization.
- (16) Subjects with score > 12 for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS).
- (17) Vulnerable study population
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motilitone 30mg
Motilitone will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study.
Subjects will be expected to take this medication for 4 weeks.
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30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks
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Placebo Comparator: Placebo
Placebo (same formulation as Motilitone but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study.
Subjects will be expected to take this tablet for 4 weeks.
|
Placebo, in tablet form, to be taken 3 times daily for 4 weeks.
The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in maximum tolerated volume by nutrient drink test
Time Frame: week -2, week 4
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week -2, week 4
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Change in aggregate symptom score by nutrient drink test
Time Frame: week -2, week 4
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week -2, week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
September 5, 2014
First Submitted That Met QC Criteria
February 11, 2015
First Posted (Estimate)
February 19, 2015
Study Record Updates
Last Update Posted (Actual)
May 21, 2019
Last Update Submitted That Met QC Criteria
May 20, 2019
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moti_FD_II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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