Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Mark Feinglos

Status and phase

Withdrawn

Phase 4

Conditions

Vomiting

Diabetic Gastroparesis

Nausea

Gastroparesis

Treatments

Drug: tadalafil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01326117

Pro00027389

Details and patient eligibility

About

The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1 diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes diagnosis
Age 18 - 65 years (inclusive)
Hemoglobin A1c ≤ 10.5% within the last 4 months
Diagnosis of gastroparesis, or symptoms consistent with gastroparesis (early satiety, chronic intermittent nausea or vomiting with food intake)
Patient has gastroparesis confirmed on screening study
A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea, or child-bearing potential with negative serum hCG prior to each gastric emptying study.

Exclusion criteria

Active nitrate use (e.g. Cialis, Viagra, Levitra, nitroglycerin, Isordil, Imdur, amyl nitrate/poppers)
Fasting fingerstick glucose > 250 mg/dL
History of abdominal surgery including gastric banding procedure
Patient is on chronic parenteral feeding
Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
Regular opiate use
Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycemia requiring medical intervention, diabetic ketoacidosis, admission for control diabetes or complications of diabetes
Acute severe gastroenteritis
The patient has participated in another clinical trial in the last 30 days.
Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study [e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics/analog, amylin analog]
History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator make the subject unsuitable for inclusion in this clinical study.
Chronic angina or NYHA class III or IV CHF
Concurrent use of ketoconazole or itraconazole
History of severe vision loss, retinitis pigmentosa, or non-arteritic anterior ischemic optic neuropathy (NAION)
History of CVA
Pregnant females as determined by positive serum hCG test
Lactating females
Uncontrolled hypertension (SBP > 160 or DBP > 100)
Hypotension (SBP < 90 or DBP < 60)
Other major medical conditions: priapism, sickle cell anemia, multiple myeloma, leukemia, active cancer diagnosis, HIV/AIDS, alcoholism, or bleeding diathesis.
Intolerance to active or inactive ingredients of Cialis, or intolerance to other PDE-5 inhibitors.