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Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01326117
Recruitment Status : Withdrawn (lack of patients who meet inclusion criteria; there was one screen failure)
First Posted : March 30, 2011
Last Update Posted : July 29, 2014
Duke University
Eli Lilly and Company
Information provided by (Responsible Party):
Mark Feinglos, Duke University

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetic Gastroparesis Nausea Vomiting Drug: tadalafil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
Study Start Date : April 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Experimental: tadalafil Drug: tadalafil
7 days of Cialis for Daily Use (5mg)
Other Name: Cialis

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326117

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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
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Principal Investigator: Mark N Feinglos, MD, CM Duke University

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Responsible Party: Mark Feinglos, Division Chief, Department of Endocrinology, Diabetes, and Metabolism, Duke University Identifier: NCT01326117     History of Changes
Other Study ID Numbers: Pro00027389
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
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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