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Completed

NCT Number: NCT02188472

Pentriox - Induction of Oxidative Stress

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.

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Key information

Conditions

Oxidative Stress

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Clinical Pharmacology

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penicillin V

Drug

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

Other names: Penicillin V, Pancillin

Trimethoprim

Drug

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

Other names: Trimethoprim, Trimopan

Placebo

Drug

Placebo: 2 tablets should be taken twice daily

Primary outcomes

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

    Time frame: Change from Baseline after seven days of treatment

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

    Time frame: Change from Baseline after seven days of treatment

Secondary outcomes

  1. Malondialdehyde

    Time frame: At the screening visit and at the final visit

Sponsors and collaborators

Lead sponsor

Henrik Enghusen Poulsen

Other

Collaborators

  • Klinisk Biokemisk Afdeling
  • Klinisk farmakologisk Afdeling
  • Sektion for Biomedicin Institut for Veterinær Patobiologi

Registry information

Official study title

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

Acronym: PENTRIOX

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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