Pentriox - Induction of Oxidative Stress (PENTRIOX)

July 9, 2014 updated by: Henrik Enghusen Poulsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Trimethoprim, Trimopan
Placebo Comparator: Placebo
2 Placebo Tablets twice daily for 7 days
Drug: Placebo
Placebo: 2 tablets should be taken twice daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Malondialdehyde
Time Frame: At the screening visit and at the final visit
At the screening visit and at the final visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henrik Enghusen Poulsen

Collaborators

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

Investigators

  • Principal Investigator: Henrik E Poulsen, MD, Department Head

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEN1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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