GastroparesisPhase 4NCT01326117
Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
A Phase 4 study testing tadalafil in people with Gastroparesis and Diabetic Gastroparesis, run by Mark Feinglos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis, Diabetic Gastroparesis, Nausea
- What is being tested?
- tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Gastroparesis, Diabetic Gastroparesis, Nausea, Vomiting
- Being tested
- tadalafil
- Keywords
- gastroparesis, gastric emptying, diabetes, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases, Phosphodiesterase Inhibitors, Neurologic Manifestations, Paralysis, Signs and Symptoms, Pharmacologic Actions
- Medical subject headings
- Gastroparesis, Nausea, Vomiting, Diabetes Mellitus, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Also called Cialis
7 days of Cialis for Daily Use (5mg)
| Study group | Role | What they receive |
|---|---|---|
| tadalafil | Experimental | Not described Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in Gastric Emptying Study residual tracer amount
change in gastric emptying compared to baseline as measured by gastric emptying time.
Measured: 7 days with intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: lack of patients who meet inclusion criteria; there was one screen failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Feinglos
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Eli Lilly and Company
- Responsible party
- Sponsor-investigator, Mark Feinglos, Duke University
- Investigators
- Mark N Feinglos, MD, CM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326117
- Sponsor's protocol ID
- Pro00027389
- Status last verified
- Jul 2014
- First submitted
- 29 Mar 2011
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT01326117
- Acronym / sponsor ID
- Pro00027389
- Conditions
- Gastroparesis, Diabetic Gastroparesis, Nausea, Vomiting
- Keywords
- gastroparesis, gastric emptying, diabetes, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases, Phosphodiesterase Inhibitors, Neurologic Manifestations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of patients who meet inclusion criteria; there was one screen failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mark FeinglosUniversity, hospital or other
- Collaborators
- Duke University, Eli Lilly and Company
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tadalafil | Experimental | Drug: tadalafil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tadalafilAlso: Cialis7 days of Cialis for Daily Use (5mg) | Drug | tadalafil |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark N Feinglos, MD, CM principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tadalafil in people with Gastroparesis and Diabetic Gastroparesis, run by Mark Feinglos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Gastric Emptying Study residual tracer amount (time frame: 7 days with intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.