Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510195-31-00

Acronym

NAT-19/GPX

Enrollment

202

Registered

2024-08-01

Start date

2023-01-03

Completion date

2025-06-19

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic or Diabetic Gastroparesis

Brief summary

Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)

Detailed description

Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6), Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD

Interventions

DRUGNAT01

DRUGNAT03

DRUGPlacebo film coated tablets

DRUGNAT02

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)	—

Secondary

Measure	Time frame
Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6), Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD	—

Countries

Austria, Belgium, France, Germany, Italy, Latvia, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026