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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01149369
First received: June 22, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Gastroparesis
Drug: Aprepitant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    • 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

  • Physiology [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aprepitant
Aprepitant 125 mg per day
Drug: Aprepitant
Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Other Name: Emend
Placebo Comparator: Aprepitant-placebo
Placebo aprepitant 125mg per day
Drug: Placebo
Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Other Name: placebo

Detailed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149369

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: William Snape, MD    415-600-1138    snapew@sutterhealth.org   
Contact: Candice Lee    (415) 600-1155    LeeCL@cpmcri.org   
Sub-Investigator: William Snape, MD         
Principal Investigator: Pankaj J Pasricha, MD         
Stanford University Recruiting
Stanford, California, United States, 94305-5187
Contact: Linda B Nguyen, MD    650-725-3362    nguyenlb@stanford.edu   
Contact: Nighat Ullah, MD    (650) 721-7216    nullah@stanford.edu   
Principal Investigator: Pankaj J Pasricha, MD         
Sub-Investigator: Linda B Nguyen, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Thomas Abell, MD    502-852-7963    thomas.abell@louisville.edu   
Contact: Karen Beatty, RN    (502) 540-1428    karen.beatty@louisville.edu   
Principal Investigator: Thomas Abell, MD         
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Pankaj Pasricha, MD    410-550-6871    ppasric1@jhmi.edu   
Contact: Yale Kim, MS, MHS    (410) 550-6871    yale@jhmi.edu   
Principal Investigator: Pankaj J Pasricha, MD         
Sub-Investigator: John Clarke, MD         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: William L Hasler, MD    734-936-8644    whasler@umich.edu   
Contact: Nara Wootten    (734) 615-6723    smao@med.umich.edu   
Principal Investigator: William L Hasler, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kenneth L Koch, MD    336-713-7333    kkoch@wakehealth.edu   
Contact: Judy Hooker    336-713-7301    jhooker@wakehealth.edu   
Principal Investigator: Kenneth L Koch, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P Parkman, MD    215-707-7579    henry.parkman@temple.edu   
Contact: Kellie Simmons, CRNP    215-707-5477    kellie.simmons@temple.edu   
Principal Investigator: Henry P Parkman, MD         
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Contact: Irene W Sarosiek, MD    915-545-6618    irene.sarosiek@ttuhsc.edu   
Contact: Natalia Vega    (915) 545-7399    Natalia.vega@ttuhsc.edu   
Principal Investigator: Richard W McCallum, MD         
Sub-Investigator: Irene Sarosiek, MD         
Sponsors and Collaborators
Investigators
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01149369     History of Changes
Other Study ID Numbers: IND - DK-GpCRC-4APRON, U01DK073983, U01DK073975, U01DK073985, U01DK074007, U01DK073974, U01DK074008, U01DK074035
Study First Received: June 22, 2010
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
gastroparesis
nausea
vomiting

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroparesis
Nausea
Vomiting
Neurologic Manifestations
Paralysis
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014