A Study of Motilitone to Treat Functional Dyspepsia

Overview

About this study

This study is to evaluate the effectiveness of the investigational drug motilitone at 90 mg in patients with functional dyspepsia as measured by change in maximum tolerated volume and the aggregate symptom score on the nutrient drink test.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Fulfills Rome III criteria for functional dyspepsia
    • 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
  • At least a moderate or severe level within the previous 3 months for two of the following eight symptoms (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe)
    • Upper abdominal pain
    • Excessive belching
    • Vomiting 
    • Nausea
    • Early satiation
    • Upper abdominal bloating
    • Postprandial fullness
    • Upper abdominal discomfort
  • Should be able to provide a written informed consent

Exclusion Criteria

  • Currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study
  • Women of childbearing potential who are not using contraception and pregnant or lactating women
  • Had surgery that may affect gastrointestinal motility
  • Has known history of gastric bleeding, intestinal obstruction or perforation
  • Has known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis
  • Has 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
  • Has liver dysfunction (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase is at least 2.5 times higher than ULN)
  • Has renal dysfunction (Serum creatinine level is at least 1.5 times higher than ULN)
  • Has a serious cardiovascular (including known baseline QT prolongation defined by >450 msec) or respiratory illness
  • Has a diagnosed psychotic illness, substance dependence or alcoholism
  • Has been 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
  • Medications that can affect QT within last 2 weeks of randomization
  • On herbal supplements for Functional Dyspepsia within last 2 weeks of randomization
  • Gastric electric stimulator in place
  • On narcotics or benzodiazepines within 7 days of randomization
  • Score > 12 for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS)
  • Vulnerable study subject

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Madhusudan Grover, M.B.B.S.

Closed for enrollment

Contact information:

Wendy Sundt CCRP

(507)266-6004

Sundt.Wendy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20190909

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