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Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

This study has been withdrawn prior to enrollment.
(lack of patients who meet inclusion criteria; there was one screen failure)
Duke University
Eli Lilly and Company
Information provided by (Responsible Party):
Mark Feinglos, Duke University Medical Center Identifier:
First received: March 29, 2011
Last updated: July 25, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Diabetic Gastroparesis
Drug: tadalafil
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • improvement in Gastric Emptying Study residual tracer amount [ Time Frame: 7 days with intervention ]
    change in gastric emptying compared to baseline as measured by gastric emptying time.

Enrollment: 0
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tadalafil Drug: tadalafil
7 days of Cialis for Daily Use (5mg)
Other Name: Cialis


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01326117

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mark Feinglos
Duke University
Eli Lilly and Company
Principal Investigator: Mark N Feinglos, MD, CM Duke University
  More Information

Responsible Party: Mark Feinglos, Division Chief, Department of Endocrinology, Diabetes, and Metabolism, Duke University Medical Center Identifier: NCT01326117     History of Changes
Other Study ID Numbers: Pro00027389
Study First Received: March 29, 2011
Last Updated: July 25, 2014

Keywords provided by Duke University:
Pharmacologic Actions
gastric emptying
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Phosphodiesterase Inhibitors
Neurologic Manifestations
Signs and Symptoms

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on May 23, 2017