Study of Motilitone to Treat Functional Dyspepsia

NCT ID: NCT02365701

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-02-28

Brief Summary

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.

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motilitone 30mg

Intervention Type: DRUG

30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Motilitone 30mg

30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• (1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following:

1. Bothersome postprandial fullness

2. Early satiation

3. Epigastric pain

4. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madhusudan Grover, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

Moti_FD_II

Identifier Type: -

Identifier Source: org_study_id