To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose (NCT05557448) | Clinical Trial Compass
RecruitingPhase 2
To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
Taiwan24 participantsStarted 2023-05-01
Plain-language summary
To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Poisoning and hospitalized patients taking acetaminophen.
* Acute ingestion of more than 150 mg/kg or plasma concentration of Acetaminophen is above the treatment line on single acute acetaminophen overdose nomogram.
* Male or female with age more than 20 years at Screening.
* Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments.
Exclusion Criteria:
* Subjects with Sequential Organ Failure Assessment (SOFA) Score higher than 12.
* Subjects who fulfilled the King's College Hospital (KCH) Criteria for liver transplantation.
* Subjects who was conscious disturbance.
* History of allergic response(s) to N-acetylcysteine (NAC), mannitol, sucralose or related drugs.
* Subject who was unable to take medicine by oral route.
* Receiving any investigational drug within 30 days prior to first dosing.
* Subject who had attacked asthma or bronchitis combined with medication therapy within six months prior to enrollment.
* Donating greater than 150 mL of blood within two months prior to first dosing or donating plasma (e.g. plasmapheresis) within 14 days prior to first dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
* Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at baseline.
* Anuria, pulmonary congestion, severe congestive heart failure, brain hemorrhage, or any conditions that …