Pentriox - Induction of Oxidative Stress
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oxidative Stress
Intervention: Penicillin V (Drug); Trimethoprim (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Henrik Enghusen Poulsen Official(s) and/or principal investigator(s):
Henrik E Poulsen, MD, Principal Investigator, Affiliation: Department head
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.
Clinical Details
Official title: PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Urinary excretion of 8-oxoguanosine (nmol/24h)Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)
Secondary outcome: Malondialdehyde
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
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
Locations and Contacts
Department of Clinical Pharmacology, Copenhagen 2100, Denmark
Additional Information
Starting date: November 2010
Last updated: July 9, 2014
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