Phase 2
N=126
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT01149369 ↗Enrolled (actual)
126
Serious AEs
0.8%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Improvement in Nausea — 29; 25 participants — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aprepitant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement in Nausea |
29; 25 | 0.43 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) |
-2.5; -1.2 | 0.03 sig |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) |
-0.5; -0.4 | 0.94 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) |
-0.5; -0.7 | 0.73 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score |
-0.5; -0.4 | 0.22 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity |
-0.8; -0.5 | 0.06 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity |
-0.4; -0.2 | 0.24 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity |
-0.7; -0.3 | 0.01 sig |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity |
-0.6; -0.4 | 0.22 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity |
0.1; 0.08 | 0.51 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity |
-0.6; -0.4 | 0.12 |
| SECONDARY Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity |
-0.7; -0.4 | 0.02 sig |
| SECONDARY Clinical Global Patient Impression Score (Patient-rated) |
1.3; 1.0 | 0.17 |
| SECONDARY Liver Enzymes and Proteins: Alanine Aminotransferase (ALT) |
2.3; 0.8 | 0.59 |
| SECONDARY Liver Enzymes and Proteins: Aspartate Aminotransferase (AST) |
3.1; 0.9 | 0.61 |
| SECONDARY Liver Enzymes and Proteins: Total Protein |
0.0; -0.1 | 0.23 |
| SECONDARY Hemoglobin A1c (HbA1c) |
-0.1; 0.1 | 0.97 |
| SECONDARY Glucose |
9.6; 7.0 | 0.77 |
| SECONDARY Liver Enzymes and Proteins: Albumin |
-0.1; -0.1 | 0.46 |
| SECONDARY Hemoglobin |
-0.1; -0.2 | 0.44 |
| SECONDARY Hematocrit |
-0.4; -0.4 | 0.77 |
| SECONDARY White Blood Cell Count (WBC) |
-0.3; -0.3 | 0.80 |
| SECONDARY Red Blood Cell Count (RBC) |
-0.1; -0.1 | 0.88 |
| SECONDARY Platelet Count |
-7.3; 4.8 | 0.17 |
| SECONDARY Carbon Dioxide |
-0.4; 0.4 | 0.07 |
| SECONDARY Chloride |
0.6; -0.2 | 0.53 |
| SECONDARY Sodium |
-0.3; -0.7 | 0.93 |
| SECONDARY Potassium |
0.1; 0.0 | 0.52 |
| SECONDARY Calcium |
-0.1; -0.1 | 0.76 |
| SECONDARY Blood Urea Nitrogen (BUN) |
-0.9; -0.3 | 0.45 |
| SECONDARY Magnesium |
0.0; -0.0 | 0.18 |
| SECONDARY Creatinine |
-0.1; 0.0 | 0.008 sig |
| SECONDARY PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score |
-1.3; -0.7 | 0.001 sig |
| SECONDARY PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore |
-1.7; -0.7 | <0.001 sig |
| SECONDARY PAGI-SYM Severity Index: Fullness/Early Satiety Subscore |
-1.0; -0.7 | 0.13 |
| SECONDARY PAGI-SYM Severity Index: Bloating Subscore |
-1.2; -0.6 | 0.004 sig |
| SECONDARY PAGI-SYM Severity Index: Upper Abdominal Pain Subscore |
-1.1; -0.6 | 0.08 |
| SECONDARY PAGI-SYM Severity Index: GERD Subscore |
-1.1; -0.6 | 0.007 sig |
| SECONDARY PAGI-SYM Severity Index: Nausea Severity |
-1.8; -1.0 | 0.005 sig |
| SECONDARY PAGI-SYM Severity Index: Vomiting Severity |
-1.6; -0.5 | 0.001 sig |
| SECONDARY PAGI-SYM Severity Index: Retching Severity |
-1.7; -0.8 | 0.003 sig |
| SECONDARY PAGI-SYM Severity Index: Stomach Fullness Severity |
-1.1; -0.5 | 0.03 sig |
| SECONDARY PAGI-SYM Severity Index: Unable to Finish Meal Severity |
-0.8; -0.6 | 0.16 |
| SECONDARY PAGI-SYM Severity Index: Excessive Fullness Severity |
-1.1; -0.6 | 0.05 |
| SECONDARY PAGI-SYM Severity Index: Loss of Appetite Severity |
-0.9; -0.9 | 0.72 |
| SECONDARY PAGI-SYM Severity Index: Bloating Severity |
-1.2; -0.5 | 0.001 sig |
| SECONDARY PAGI-SYM Severity Index: Stomach Distention Severity |
-1.1; -0.7 | 0.04 sig |
| SECONDARY PAGI-SYM Severity Index: Upper Abdominal Pain Severity |
-1.0; -0.5 | 0.14 |
| SECONDARY PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity |
-1.2; -0.7 | 0.07 |
| SECONDARY PAGI-SYM Severity Index: Lower Abdominal Pain Severity |
-0.8; -0.6 | 0.19 |
| SECONDARY PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity |
-1.1; -0.6 | 0.04 sig |
| SECONDARY PAGI-SYM Severity Index: Heartburn During the Day Severity |
-1.2; -0.6 | 0.02 sig |
| SECONDARY PAGI-SYM Severity Index: Heartburn When Lying Down Severity |
-1.2; -0.7 | 0.06 |
| SECONDARY PAGI-SYM Severity Index: Chest Discomfort During the Day Severity |
-1.1; -0.7 | 0.09 |
| SECONDARY PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity |
-0.9; -0.6 | 0.17 |
| SECONDARY PAGI-SYM Severity Index: Regurgitation During the Day Severity |
-1.2; -0.5 | 0.009 sig |
| SECONDARY PAGI-SYM Severity Index: Regurgitation When Lying Down Severity |
-1.3; -0.5 | 0.004 sig |
| SECONDARY PAGI-SYM Severity: Bitter Taste Severity |
-0.8; -0.5 | 0.10 |
| SECONDARY PAGI-SYM Severity Index: Constipation Severity |
-0.8; -0.3 | 0.13 |
| SECONDARY PAGI-SYM Severity Index: Diarrhea Severity |
-0.1; -0.2 | 0.98 |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Total Score |
-0.8; -0.5 | 0.007 sig |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score |
-1.1; -0.7 | 0.06 |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score |
-1.3; -0.7 | 0.001 sig |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score |
-0.7; -0.7 | 0.28 |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score |
-0.5; 0.1 | 0.05 |
| SECONDARY Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score |
-0.8; -0.4 | 0.08 |
| SECONDARY Brief Pain Inventory: Severity Score |
-1.0; -0.7 | 0.53 |
| SECONDARY Brief Pain Inventory: Interference Score |
-1.1; -1.0 | 0.38 |
| SECONDARY Beck Depression Inventory (BDI) Score |
-4.6; -2.4 | 0.09 |
| SECONDARY State-Trait Anxiety Inventory (STAI): State Anxiety Score |
-3.1; -1.7 | 0.28 |
| SECONDARY State-Trait Anxiety Inventory (STAI): Trait Anxiety Score |
-1.8; -0.7 | 0.30 |
| SECONDARY Satiety Test, Volume Consumed |
-13.0; 9.2 | 0.40 |
| SECONDARY Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement |
-4.6; 2.8 | 0.28 |
| SECONDARY Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement |
2.1; 0.5 | 0.47 |
| SECONDARY Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement |
1.0; -1.0 | 0.68 |
| SECONDARY Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement |
1.0; 0.8 | 0.48 |
| SECONDARY Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement |
1.5; -1.6 | 0.43 |
| SECONDARY Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement |
-2.1; -0.8 | 0.01 sig |
| SECONDARY Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement |
2.1; -0.2 | 0.57 |
| SECONDARY Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement |
-0.8; -0.5 | 0.34 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01149369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.