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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT05749068
Eligibility Criteria:
Inclusion Criteria:
* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
Physical Status Classification System 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine.
Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form
Exclusion Criteria:
* • Known or suspected gastrointestinal obstructions, strictures or fistula
* Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator
* Gastroparesis
* A swallowing disorder
* Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
* Urinary obstruction
* Porphyria
* Glucose-6-phosphate dehydrogenase deficiency
* Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding.
* Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator.
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study.
* A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05749068
Study Brief:
Protocol Section:
NCT05749068