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This study has been withdrawn prior to enrollment.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

March 29, 2011
July 25, 2014
April 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01326117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroparesis
  • Diabetic Gastroparesis
  • Nausea
  • Vomiting
Drug: tadalafil
7 days of Cialis for Daily Use (5mg)
Other Name: Cialis
Experimental: tadalafil
Intervention: Drug: tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326117
Pro00027389
Yes
Mark Feinglos, Duke University Medical Center
Mark Feinglos
  • Duke University
  • Eli Lilly and Company
Principal Investigator: Mark N Feinglos, MD, CM Duke University
Duke University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP