Clinical trial NCT01326117: Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
Official title: Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gastroparesis
Diabetic Gastroparesis
Nausea
Vomiting
Keywords: gastroparesis
gastric emptying
diabetes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Phosphodiesterase Inhibitors
Neurologic Manifestations
Paralysis
Signs and Symptoms
Pharmacologic Actions
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Eli Lilly and Company
First posted: 2011-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: improvement in Gastric Emptying Study residual tracer amount
timeFrame: 7 days with intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mark N Feinglos, MD, CM
role: PRINCIPAL_INVESTIGATOR
References: