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

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

This study is not yet open for participant recruitment.

Verified October 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

First Received on June 22, 2010. Last Updated on October 20, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT01149369

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Aprepitant Fosaprepitant

U.S. FDA Resources

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:	February 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Aprepitant	Drug: Aprepitant Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks Other Name: Emend
Placebo Comparator: Aprepitant-placebo	Drug: Placebo Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks

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 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 2xULN 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

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

Contacts

Contact: James Tonascia, PhD	410-955-3704	jtonasci@jhsph.edu
Contact: Aynur Unalp-Arida, MD, PhD	410-614-4851	aunalp@jhsph.edu

Locations

United States, California
California Pacific Medical Center	Not yet recruiting
San Francisco, California, United States, 94115
Contact: William Snape, MD 415-516-9127 snapew@sutterhealth.org
Contact: Mary Greene, RN (415) 600-1367 greenem@cpmcri.org
Sub-Investigator: William Snape, MD
Stanford University	Not yet recruiting
Stanford, California, United States, 94305-5187
Contact: Pankaj J Pasricha, MD 650-725-3362 Pasricha@stanford.edu
Contact: Nighat Ullah, MD (650) 723-3567 nullah@stanford.edu
Principal Investigator: Pankaj J Pasricha, MD
Sub-Investigator: Linda B Nguyen, MD
United States, Michigan
University of Michigan Medical Center	Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: William L Hasler, MD 734-936-8644 whasler@umich.edu
Contact: Michelle Castle (734) 615-6723 michcast@umich.edu
Principal Investigator: William L Hasler, MD
United States, Mississippi
University of Mississippi Medical Center	Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Thomas L Abell, MD 601-815-3463 tabell@medicine.umsmed.edu
Contact: Olivia Henry, RN (601) 815-1770 ohenry@medicine.umsmed.edu
Principal Investigator: Thomas L Abell, MD
United States, North Carolina
Wake Forest University Health Sciences	Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kenneth L Koch, MD 336-713-7333 kkoch@wfubmc.edu
Contact: Judy Hooker 336-713-7301 jhooker@wfubmc.edu
Principal Investigator: Kenneth L Koch, MD
United States, Pennsylvania
Temple University Hospital	Not yet 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	Not yet recruiting
El Paso, Texas, United States, 79905
Contact: Richard W McCallum, MD 915-545-6618 richard.mccallum@ttuhsc.edu
Contact: Irene Sarosiek, MD (915) 545-6618 irene.sarosiek@ttuhsc.edu
Principal Investigator: Richard W McCallum, MD
Sub-Investigator: Irene Sarosiek, MD

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Director:

Frank Hamilton, MD, MPH

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Additional Information:

Gastroparesis Clinical Research Consortium website This link exits the ClinicalTrials.gov site

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:	October 20, 2011
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:

Nausea
Vomiting
Gastroparesis
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations

Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 15, 2012