Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

NCT ID: NCT01326117

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Gastroparesis; Diabetic Gastroparesis; Nausea; Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tadalafil

Group Type: EXPERIMENTAL

tadalafil

Intervention Type: DRUG

7 days of Cialis for Daily Use (5mg)

Interventions

tadalafil

7 days of Cialis for Daily Use (5mg)

Intervention Type: DRUG

Other Intervention Names

Cialis

Eligibility Criteria

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.

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

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Mark Feinglos

OTHER

Sponsor Role: lead

Responsible Party

Mark Feinglos

Division Chief, Department of Endocrinology, Diabetes, and Metabolism

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark N Feinglos, MD, CM

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00027389

Identifier Type: -

Identifier Source: org_study_id