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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.
Verified March 2013 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: March 27, 2013
Last verified: March 2013
History of Changes

June 22, 2010
March 27, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01149369 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
    • Gastric emptying breath test measures at 30 min, 1 hour, 2 hours, and 3 hours
    • 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
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastroparesis
  • Drug: Aprepitant
    Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
    Other Name: Emend
  • Drug: Placebo
    Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
    Other Name: placebo
  • Active Comparator: Aprepitant
    Aprepitant 125 mg per day
    Intervention: Drug: Aprepitant
  • Placebo Comparator: Aprepitant-placebo
    Placebo aprepitant 125mg per day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
May 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: James Tonascia, PhD 410-955-3704 jtonasci@jhsph.edu
Contact: Aynur Unalp-Arida, MD, PhD 410-614-4851 aunalp@jhsph.edu
United States
 
NCT01149369
IND - DK-GpCRC-4APRON, U01DK073983, U01DK073975, U01DK073985, U01DK074007, U01DK073974, U01DK074008, U01DK074035
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP