NCT04028492Phase 3Completed

Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-02-21Actual

Enrollment · participants979Actual

Source updated2026-09-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-07 · 1 field changed

Enrollment · participant count

Recorded edit

− Previous value

count: 992; type: ACTUAL

+ Updated value

count: 979; type: ACTUAL

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Posted 2026-04-20 · 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)

+ Updated value

measure: Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population

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Study details

Conditions studied

Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis

Treatments or interventions studied

TradipitantDrug
PlaceboDrug
Open Label TradipitantDrug

Primary outcomes · main study measures

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measure: Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population; description: The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the biweekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.; timeFrame: 12 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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