Clinical study to show if Naronapride tablets are safe and efficient for treatment of delayed stomach emptying and to find the optimal dose

Phase 1

• Conditions: idiopathic or diabetic gastroparesis; MedDRA version: 20.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10021227Term: Idiopathic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-002254-86-NL
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- Men and women between =18 and =75 years of age
-History of idiopathic or diabetic gastroparesis cardinal symptoms for =3 months
-Evidence of delayed gastric emptying
-Average weekly total symptom score of =2.0
- Body Mass Index =16 and <35 kg/m2
- Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 256
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

-Participants without access to an internet-capable terminal and/or without an own e-mail address
-History of major gastrointestinal surgery
-Intrapyloric botulinum toxin injection within 12 months
-Active Gastric stimulator implant
-Known secondary causes of gastroparesis
-Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis.;Secondary Objective: To determine the optimal dose-level of naronapride after completion of a 12-week treatment in participants with at least moderate idiopathic or diabetic gastroparesis,<br>To evaluate safety and tolerability of naronapride compared to placebo in participants with at least moderate idiopathic or diabetic gastroparesis;Primary end point(s): Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6);Timepoint(s) of evaluation of this end point: visit 6 (Day 85)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)<br>-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<br>;Timepoint(s) of evaluation of this end point: visit 6 (Day 85)