Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02298868
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis
* Presence of muscle cramps on a regular basis
Exclusion Criteria:
* Allergy or hypersensitivity to Baclofen
* Active or untreated Portosystemic encephalopathy
* Active alcohol or substance abuse
* Age less than 18
* Pregnancy
* Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent
* Concomitant use of Tricyclic Antidepressant due to drug interaction
* History of chronic kidney disease defined by GFR \< 30 (using MDRD equation)
* Subject is institutionalized or a prisoner
* Inability or unwillingness to give informed consent
* Expected lifespan less than 3 months
* Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02298868
Study Brief:
Protocol Section:
NCT02298868