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Pentriox - Induction of Oxidative Stress (PENTRIOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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


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




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

Secondary Outcome Measures :
  1. Malondialdehyde [ Time Frame: At the screening visit and at the final visit ]


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

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
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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