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Pentriox - Induction of Oxidative Stress

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oxidative Stress

Intervention: Penicillin V (Drug); Trimethoprim (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Henrik Enghusen Poulsen

Official(s) and/or principal investigator(s):
Henrik E Poulsen, MD, Principal Investigator, Affiliation: Department head


The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and trimethoprim's possible induction of oxidative stress in human cells. The induction is examined by comparing changes in oxidative stress in the treatment group with the change in a placebo group. The study is a randomized-based placebo-controlled study. Each treatment group consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.

Clinical Details

Official title: PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Urinary excretion of 8-oxoguanosine (nmol/24h)

Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)

Secondary outcome: Malondialdehyde


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Male.


Inclusion Criteria:

- Caucasian

- healthy men

- non-smoker

- 18-35 years

- BMI: 18-30

Exclusion Criteria:

- Smoker

- high blood pressure

- allergies towards any of the tested medicine

- galactose-intolerance

- abnormal lipid profile

- CRP > 10

- Glucose/galactose-malabsorption

- Use of medications and herbal remedies that affect/are affected by v-penicillin and


- intake of narcotics 2 months prior to trial

- intake of supplements 1 month prior to trial

- bronchial asthma

- allergies

- heart deficiencies

- brady cardia

- kidney disease

- liver disease

- hypo-potassium

- phenylketonuria

Locations and Contacts

Department of Clinical Pharmacology, Copenhagen 2100, Denmark
Additional Information

Starting date: November 2010
Last updated: July 9, 2014

Page last updated: August 23, 2015

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