Pentriox - Induction of Oxidative Stress

NCT02188472 — Phase 1, Completed, 90 participants, Henrik Enghusen Poulsen

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

Registry	NCT02188472, acronym PENTRIOX
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	90 (Actual)
Sponsor	Henrik Enghusen Poulsen (Other); collaborators: Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi
Conditions	Oxidative Stress
Interventions	Penicillin V, Trimethoprim, Placebo (Drug)
Dates	start 2010-11-01, primary completion 2011-02-01, completion 2011-02-01, first posted 2014-07-11, last updated 2014-07-11
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Penicillin V	Active comparator	Drug: Penicillin V	Penicillin V 2 tablets of 330 mg twice dayly for 7 days
Trimethoprim	Active comparator	Drug: Trimethoprim	2 Tablet Trimethoprim of 100 mg twice daily for 7 days
Placebo	Placebo comparator	Drug: Placebo	2 Placebo Tablets twice daily for 7 days

Penicillin V (Drug), also known as Penicillin V, Pancillin: Penicillin V: 2 x 330mg tablets should be taken twice daily
Trimethoprim (Drug), also known as Trimethoprim, Trimopan: Trimopan: 2 x 100mg tablets should be taken twice daily
Placebo (Drug): Placebo: 2 tablets should be taken twice daily

+Outcome measures

Primary outcomes

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 outcomes

Malondialdehyde [At the screening visit and at the final visit]

+Eligibility

Sex: Male, ages: 18 Years to 35 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Department of Clinical Pharmacology	Copenhagen	Denmark

+Investigators

Henrik E Poulsen, MD, Principal investigator, Department head