Do you suffer from a feeling of fullness after eating (Gastroparesis)?
Consider enrolling in the NAT-19 study, which is researching a study medication that may help.
What is the NAT-19 study?
This study is part of the development program of a new medication for Gastroparesis, an illness where the stomach does not empty in a normal way but with delay; which can cause symptoms such as nausea, vomiting, abdominal pain, bloating and feeling overly full after meals. So far, there is no medication for treatment of this illness available on the European market – only surgical procedures and medications to ameliorate the symptoms.
What is the study medication?
The name of the medication under investigation in this study is Naronapride. Naronapride has previously been tested in healthy persons and for other illnesses of the digestive system. Aim of the present study is to find out, if the medication is effective for treatment of two forms of Gastroparesis – ideopathic (this means “whithout known cause”) and diabetic (i.e. as secondary complication of diabetes) gastroparesis.
Moreover, potential undesirable effects of the treatment shall be recorded. Patients, participating in the study will be treated with tablets containing one of three different doses of Naronapride or with Placebo (tablets identical in appearance and composition to the others but without Naronapride). Afterwards, it will be evaluated wich dosage has the most favourable efficacy-to-safety-profile.
What can study participants expect?
Participation in the NAT-19 study lasts up to 20 weeks and includes the following steps:
- Read and sign the Informed Consent Form (ICF).
- Perform health assessments to confirm if you qualify for the study.
- Be assigned at random (like the flip of a coin) to receive either the study medication or placebo (no active ingredients).
- 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.
- Visit the study clinic for follow-up health assessments, 1 week after your last dose.
Who can join the study?
You may be eligible to join if you meet the following criteria*:
- Age 18 or older.
- Diagnosed with ideopathic or diabetic gastroparesis and fulfill the participation criteria
- Diagnosed with gastroparesis, including gastrointestinal symptoms such as nausea or vomiting after eating, feeling too full after eating, bloating, and/or throat or stomach pain within the last 6 months.
- (e.g. certain other medications should not be taken and certain other diseases or conditions should not be present or have occured in the past, so as to not jeopardize the safety of the participants or confound the data raised).
- *Other criteria apply. Talk to your doctor to learn more.