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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | March 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (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
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 | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: William Snape, MD 415-516-9127 snapew@sutterhealth.org | |
| Contact: Lisa Di Maio, RN (415) 600-1155 DiMaioL@cpmcri.org | |
| Sub-Investigator: William Snape, MD | |
| Principal Investigator: Pankaj J Pasricha, MD | |
| Stanford University | Not yet 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 | Not yet recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Pankaj Pasricha, MD 410-550-1793 ppasric1@jhmi.edu | |
| Principal Investigator: Pankaj J Pasricha, 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: 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: | March 27, 2013 |
| 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 19, 2013