At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
PP100-01 (calmangafodipir) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)
In Brief
A Phase 1 clinical trial evaluating PP100-01 (calmangafodipir) and Acetylcysteine for Paracetamol Overdose. Completed, enrolled 24 participants across 1 site.
Detailed Summary
Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParacetamol Overdose
CountriesUnited Kingdom
CollaboratorsUniversity of Edinburgh, NHS Lothian
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2017
Primary CompletionAug 2018
Study CompletionNov 2018
TodayJul 2026
First PostedJun 6, 2017
Enrollment StartJun 8, 2017
Primary CompletionAug 8, 2018
Study CompletionNov 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 years ago
Interventions
PP100-01 (calmangafodipir)drug
PP100-01
Acetylcysteinedrug
NAC