Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

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.

Study Overview

• Status: Withdrawn
• Conditions: Nausea; Vomiting; Gastroparesis; Diabetic Gastroparesis
• Intervention / Treatment: Drug: tadalafil

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tadalafil	Drug: tadalafil; 7 days of Cialis for Daily Use (5mg); Other Names: Cialis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mark Feinglos
• Collaborators: Eli Lilly and Company; Duke University
• Investigators: Principal Investigator: Mark N Feinglos, MD, CM, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: diabetes; gastric emptying; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Stomach Diseases; Paralysis; Pharmacologic Actions; Signs and Symptoms; gastroparesis; Phosphodiesterase Inhibitors
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Vomiting; Gastroparesis; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: Pro00027389