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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborators:
Duke University
Eli Lilly and Company
Information provided by (Responsible Party):
Mark Feinglos, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01326117
First received: March 29, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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
Gastroparesis
Diabetic Gastroparesis
Nausea
Vomiting
Drug: tadalafil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326117

Locations
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
Investigators
Principal Investigator: Mark N Feinglos, MD, CM Duke University
  More Information

No publications provided

Responsible Party: Mark Feinglos, Division Chief, Department of Endocrinology, Diabetes, and Metabolism, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01326117     History of Changes
Other Study ID Numbers: Pro00027389
Study First Received: March 29, 2011
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nausea
Vomiting
Gastroparesis
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Phosphodiesterase Inhibitors
Tadalafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014