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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oxidative Stress | Drug: Penicillin V Drug: Trimethoprim Drug: Placebo | Phase 1 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
Denmark | |
Department of Clinical Pharmacology | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Henrik E Poulsen, MD | Department head |
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 |
Oxidative Stress antibiotics |
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 |