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PP100-01 (Calmangafodipir) for Overdose of Paracetamol

NCT03177395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-10-03

Study results available
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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.

Conditions

  • Paracetamol Overdose

Interventions

DRUG

PP100-01 (calmangafodipir)

PP100-01

DRUG

Acetylcysteine

NAC

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • NHS Lothian

    collaborator OTHER_GOV

  • Egetis Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Dear · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2018-08-08
Completion
2018-11-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03177395 on ClinicalTrials.gov