Study of Motilitone to Treat Functional Dyspepsia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/7/2018 |
| Start Date: | March 2015 |
| End Date: | June 2018 |
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.
patients with Functional Dyspepsia as measured by change in maximum tolerated volume and
aggregate symptom score on the nutrient drink test.
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
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