NCT01326117

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

March 29, 2011

Last Update Submit

July 25, 2014

Conditions

GastroparesisDiabetic GastroparesisNauseaVomiting

Keywords

gastroparesisgastric emptyingdiabetesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesPhosphodiesterase InhibitorsNeurologic ManifestationsParalysisSigns and SymptomsPharmacologic Actions

Outcome Measures

Primary Outcomes (1)

  • improvement in Gastric Emptying Study residual tracer amount

    change in gastric emptying compared to baseline as measured by gastric emptying time.

    7 days with intervention

Study Arms (1)

tadalafil

EXPERIMENTAL
Drug: tadalafil

Interventions

tadalafilDRUG

7 days of Cialis for Daily Use (5mg)

Also known as: Cialis
tadalafil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 \[e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics/analog, amylin analog\]
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

GastroparesisNauseaVomitingDiabetes MellitusStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsParalysisSigns and Symptoms

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Mark N Feinglos, MD, CM

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division Chief, Department of Endocrinology, Diabetes, and Metabolism

Study Record Dates

First Submitted

March 29, 2011

First Posted

March 30, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)