Pentriox - Induction of Oxidative Stress

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02188472

Acronym

PENTRIOX

Enrollment

Registered

2014-07-11

Start date

2010-11-30

Completion date

2011-02-28

Last updated

2014-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Oxidative Stress, antibiotics

Brief summary

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.

Interventions

DRUGPenicillin V

Penicillin V: 2 x 330mg tablets should be taken twice daily

DRUGTrimethoprim

Trimopan: 2 x 100mg tablets should be taken twice daily

DRUGPlacebo

Placebo: 2 tablets should be taken twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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 trimethoprim * 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

Design outcomes

Primary

Measure	Time frame
Urinary excretion of 8-oxoguanosine (nmol/24h)	Change from Baseline after seven days of treatment
Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)	Change from Baseline after seven days of treatment

Secondary

Measure	Time frame
Malondialdehyde	At the screening visit and at the final visit

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026