NCT01149369

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

8 active sites

Status
completed

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

June 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
2.8 years until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

May 8, 2019

Completed
Last Updated

May 8, 2019

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

June 22, 2010

Results QC Date

August 17, 2018

Last Update Submit

April 15, 2019

Conditions

Gastroparesis

Keywords

gastroparesisnauseavomiting

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Improvement in Nausea

    The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (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.

    4 weeks

Secondary Outcomes (79)

  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)

    4 weeks

  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)

    4 weeks

  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)

    4 weeks

  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score

    4 weeks

  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity

    4 weeks

  • +74 more secondary outcomes

Study Arms (2)

Aprepitant

ACTIVE COMPARATOR

Aprepitant 125 mg per day

Drug: Aprepitant

Aprepitant-placebo

PLACEBO COMPARATOR

Placebo aprepitant 125mg per day

Drug: Placebo

Interventions

AprepitantDRUG

Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks

Also known as: Emend
Aprepitant
PlaceboDRUG

Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks

Aprepitant-placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305-5187, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Related Publications (1)

  • Pasricha PJ, Yates KP, Sarosiek I, McCallum RW, Abell TL, Koch KL, Nguyen LAB, Snape WJ, Hasler WL, Clarke JO, Dhalla S, Stein EM, Lee LA, Miriel LA, Van Natta ML, Grover M, Farrugia G, Tonascia J, Hamilton FA, Parkman HP; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders. Gastroenterology. 2018 Jan;154(1):65-76.e11. doi: 10.1053/j.gastro.2017.08.033. Epub 2017 Oct 28.

    PMID: 29111115DERIVED

Related Links

MeSH Terms

Conditions

GastroparesisNauseaVomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Katherine Yates
Organization
Johns Hopkins Data Coordinating Center
kyates1@jhu.edu
443-287-0082

Study Officials

  • Frank Hamilton, MD, MPH

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 23, 2010

Study Start

April 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

May 8, 2019

Results First Posted

May 8, 2019

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Data will be deposited with the NIDDK Data Repository at the end of the funding cycle.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
The primary analysis analytic dataset will be available at the NIDDK Central Repository approximately 6 months after publication. The complete study dataset is due approximately 2 years post study publication.
Access Criteria
The NIDDDK Central Repository staff is responsible for review of requests for use of the APRON public access datasets. A NIDDK SDUC form must be submitted.
More information

Locations

US(8)