A study of Linkase in patients with Irritable Bowel Disease (IBS)

General study information7

The goal of this study is to determine the safety and efficacy of treatment with Linkase in patient diarrhea predominant IBS. You will be assigned to receive capsules with either Linkase or placebo and will need to take one capsule each day for one month.

Patient population

To enroll in this study, you will need to meet the following criteria

- men and women between 18-70 years old

- diagnosis of diarrhea predominant IBS

- currently not receiving treatment with anti-diarrheals

Study duration and compensation

After the initial study entry visit, you wil return to the study center after 1 and 2 months. You will be asked to keep a diary with notes on your general health, your IBS sysmptoms and any other medication intake. You will return to the study center after 1 months and a last time for a follow-up visit after 2 months. Total study participation in the study will be for approximately 2 months, with a total of 3 hospital visits.

The study drug will be provided to you free of charge..

This study is being sponsored by LinkPharma and will be conducted at approximately 200 centers across Europe. About 200 patients will enroll in the study.

For more information on the study sponsor and the compound, please folow the links below

- LinkPharma is the sponsor of the study

- Linkase is the compoiund being studied

- clinicaltrials.gov: the FDA (US Food and Drug Administration) database of ongoing clinical research studies

- Declaration of Helsinki: the Ethical principles that guide medical reserach involving human subjects.

 

You are welcome to ask your study staff for further information or clarification. You will have access to this study information at any time

 

 

 

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