Pentriox - Induction of Oxidative Stress (PENTRIOX)

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ClinicalTrials.gov Identifier: NCT02188472

Recruitment Status : Completed

First Posted : July 11, 2014

Last Update Posted : July 11, 2014

Sponsor:

Collaborators:

Klinisk Biokemisk Afdeling

Klinisk farmakologisk Afdeling

Sektion for Biomedicin Institut for Veterinær Patobiologi

Information provided by (Responsible Party):

Henrik Enghusen Poulsen, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oxidative Stress	Drug: Penicillin V Drug: Trimethoprim Drug: Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers
Study Start Date :	November 2010
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Penicillin V potassium Trimethoprim Penicillins Trimethoprim hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Penicillin V Penicillin V 2 tablets of 330 mg twice dayly for 7 days	Drug: Penicillin V Penicillin V: 2 x 330mg tablets should be taken twice daily Other Name: Penicillin V, Pancillin
Active Comparator: Trimethoprim 2 Tablet Trimethoprim of 100 mg twice daily for 7 days	Drug: Trimethoprim Trimopan: 2 x 100mg tablets should be taken twice daily Other Name: Trimethoprim, Trimopan
Placebo Comparator: Placebo 2 Placebo Tablets twice daily for 7 days	Drug: Placebo Placebo: 2 tablets should be taken twice daily

Outcome Measures

Primary Outcome Measures :

Urinary excretion of 8-oxoguanosine (nmol/24h) [ Time Frame: Change from Baseline after seven days of treatment ]
Urinary excretion of 8-oxodeoxoguanosine (nmol/24h) [ Time Frame: Change from Baseline after seven days of treatment ]

Secondary Outcome Measures :

Malondialdehyde [ Time Frame: At the screening visit and at the final visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188472

Locations

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Denmark
Department of Clinical Pharmacology
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Henrik Enghusen Poulsen

Klinisk Biokemisk Afdeling

Klinisk farmakologisk Afdeling

Sektion for Biomedicin Institut for Veterinær Patobiologi

Investigators

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Principal Investigator:	Henrik E Poulsen, MD	Department head

More Information

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Responsible Party:	Henrik Enghusen Poulsen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT02188472
Other Study ID Numbers:	PEN1011
First Posted:	July 11, 2014 Key Record Dates
Last Update Posted:	July 11, 2014
Last Verified:	July 2014

Keywords provided by Henrik Enghusen Poulsen, Rigshospitalet, Denmark:


Oxidative Stress antibiotics

Additional relevant MeSH terms:

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Trimethoprim Penicillins Penicillin V Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antimalarials Antiprotozoal Agents	Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents

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