Pentriox - Induction of Oxidative Stress

Oxidative Stress Clinical Trial

— PENTRIOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188472
• Other study ID #: PEN1011
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2010
• Last updated: July 9, 2014
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Drug:
• Penicillin V
Penicillin V: 2 x 330mg tablets should be taken twice daily
• Trimethoprim
Trimopan: 2 x 100mg tablets should be taken twice daily
• Placebo
Placebo: 2 tablets should be taken twice daily

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Henrik Enghusen Poulsen	Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of 8-oxoguanosine (nmol/24h)		Change from Baseline after seven days of treatment	No
Primary	Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)		Change from Baseline after seven days of treatment	No
Secondary	Malondialdehyde		At the screening visit and at the final visit	No