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

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002254-86-PL

Enrollment

320

Registered

2022-06-07

Start date

2022-09-08

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

idiopathic or diabetic gastroparesis MedDRA version: 20.1 Level: PT Classification code 10051153 Term: Diabetic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10021227 Term: Idiopathic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Naronapride 10 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Naronapride dihydrochloride trihydrate Current Sponsor code: ATI-7505 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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, 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)	—

Measure

Time frame

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, 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

Measure	Time frame
Secondary end point(s): -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 ;Timepoint(s) of evaluation of this end point: visit 6 (Day 85)	—

Countries

Australia, Austria, Belgium, France, Germany, Italy, Latvia, Netherlands, Poland, Switzerland, United Kingdom, United States

Contacts

Public ContactDept. of Clinical R&D

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de+4976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026