Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Nausea Clinical Trial

Official title:

Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01326117
• Other study ID #: Pro00027389
• Status: Withdrawn
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: July 25, 2014
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Nausea
• Vomiting

Intervention

Drug:
• tadalafil
7 days of Cialis for Daily Use (5mg)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Mark Feinglos	Duke University, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in Gastric Emptying Study residual tracer amount	change in gastric emptying compared to baseline as measured by gastric emptying time.	7 days with intervention	Yes