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Trial #NCT01149369
Gastroparesis Clinical Trials

Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial


Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial
Study ID: IND - DK-GpCRC-4APRON; Secondary ID: U01DK073983; Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 120
Start date April 2013
Completion date April 2015
Phase Phase 3
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary:
The principal objective of this multicenter, randomized, placebo-controlled trial is to
evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with
placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
Description:
APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of
treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related
disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks
after obtaining informed consent and registration. Eligible patients will consist of
patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg
per day) or placebo for 4 weeks.

The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary
(GCSIDD)for one week at baseline and for four weeks after randomization. In addition, the
nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS)14 for one
week at baseline and daily for four weeks after randomization. There will be a 2 week
washout period at the end of the treatment to ensure patient safety following the end of
treatment.
Eligibility:
Gender: Both
Age: 18 Years - N/A
Inclusion Criteria:
- Age 18 years or older at registration
- Gastric emptying scintigraphy within 2 years of registration
- Normal upper endoscopy or upper GI series within 2 years of registration
- Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21
- Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale
Exclusion Criteria:
- Another active disorder which could explain symptoms in the opinion of the investigator
- Use of narcotics more than 3 days per week
- Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
- Contraindications to aprepitant such as hypersensitivity or allergy
- Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride
- Pregnancy or nursing
- Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- Failure to give informed consent
Outcome:
Primary outcome
  • Primary Outcome Measure
    The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available VAS scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.
    Time frame: 4 weeks
Secondary outcome
  • Gastrointestinal symptoms
    Subscores for the GCSI: nausea/vomiting, postprandial fullness, bloating Subscores for the GCSI Daily Diary Individual symptom scores for nausea, retching or vomiting Global overall relief of symptom questionnaire Clinical global patient impression
    Time frame: 4 weeks
  • Physiology
    Satiety test: Volume of Ensure ® consumed during satiety testing Electrogastrography: Percent time in EGG dysrhythmias (outside 2.5-3.75 cycles per minute) Side effects to treatment requiring stopping medication
    Time frame: 4 weeks
Contacts:
  • Frank Hamilton, MD, MPH; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (Study Director)
  • Aynur Unalp-Arida, MD, PhD;
    Phone: 410-614-4851
  • James Tonascia, PhD;
    Phone: 410-955-3704
Location Country Status
California Pacific Medical Center San Francisco, California United States Recruiting
Stanford University Stanford, California United States Recruiting
University of Louisville Louisville, Kentucky United States Recruiting
Johns Hopkins Bayview Medical Center Baltimore, Maryland United States Recruiting
University of Michigan Medical Center Ann Arbor, Michigan United States Recruiting
Wake Forest University Health Sciences Winston-Salem, North Carolina United States Recruiting
Temple University Hospital Philadelphia, Pennsylvania United States Recruiting
Texas Tech University Health Sciences Center El Paso, Texas United States Recruiting
Sponsors:
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - (Lead Sponsor)

Related trials: Terms
  • nausea
  • vomiting
  • gastroparesis
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