Oxidative StressPhase 1PENTRIOXNCT02188472
Pentriox - Induction of Oxidative Stress
A Phase 1 study testing Penicillin V and Trimethoprim in people with Oxidative Stress, run by Henrik Enghusen Poulsen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Penicillin V and Trimethoprim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- healthy men
- non-smoker
- 18-35 years
- BMI: 18-30
Who cannot join
- Smoker
- high blood pressure
- allergies towards any of the tested medicine
- galactose-intolerance
- abnormal lipid profile
- CRP > 10
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Oxidative Stress
- Being tested
- Penicillin V, Trimethoprim, Placebo
- Keywords
- Oxidative Stress, antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin VDrug
Also called Penicillin V, Pancillin
Penicillin V: 2 x 330mg tablets should be taken twice daily
TrimethoprimDrug
Also called Trimethoprim, Trimopan
Trimopan: 2 x 100mg tablets should be taken twice daily
PlaceboDrug
Placebo: 2 tablets should be taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| Penicillin V | Active comparator | Penicillin V 2 tablets of 330 mg twice dayly for 7 days Receives: Drug: Penicillin V |
| Trimethoprim | Active comparator | 2 Tablet Trimethoprim of 100 mg twice daily for 7 days Receives: Drug: Trimethoprim |
| Placebo | Placebo comparator | 2 Placebo Tablets twice daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of 8-oxoguanosine (nmol/24h)
Measured: Change from Baseline after seven days of treatment
Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)
Measured: Change from Baseline after seven days of treatment
Secondary outcomes (1)
Malondialdehyde
Measured: At the screening visit and at the final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Enghusen Poulsen
- Sponsor type
- University, hospital or other
- Collaborators
- Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi
- Responsible party
- Sponsor-investigator, Henrik Enghusen Poulsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik E Poulsen, MD, Principal investigator, Department head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188472
- Sponsor's protocol ID
- PEN1011
- Acronym
- PENTRIOX
- Status last verified
- Jul 2014
- First submitted
- 1 Nov 2010
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02188472
- Acronym / sponsor ID
- PENTRIOX / PEN1011
- Conditions
- Oxidative Stress
- Keywords
- Oxidative Stress, antibiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Henrik Enghusen PoulsenUniversity, hospital or other
- Collaborators
- Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Penicillin V | Active comparator | Drug: Penicillin VPenicillin V 2 tablets of 330 mg twice dayly for 7 days |
| Trimethoprim | Active comparator | Drug: Trimethoprim2 Tablet Trimethoprim of 100 mg twice daily for 7 days |
| Placebo | Placebo comparator | Drug: Placebo2 Placebo Tablets twice daily for 7 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian
- healthy men
- non-smoker
- 18-35 years
- BMI: 18-30
Key exclusion criteria (18 listed)
- Smoker
- high blood pressure
- allergies towards any of the tested medicine
- galactose-intolerance
- abnormal lipid profile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin VAlso: Penicillin V, PancillinPenicillin V: 2 x 330mg tablets should be taken twice daily | Drug | Penicillin V |
| TrimethoprimAlso: Trimethoprim, TrimopanTrimopan: 2 x 100mg tablets should be taken twice daily | Drug | Trimethoprim |
| PlaceboPlacebo: 2 tablets should be taken twice daily | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Malondialdehyde
Time frame: At the screening visit and at the final visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik E Poulsen, MD principal investigator
Department head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Penicillin V and Trimethoprim in people with Oxidative Stress, run by Henrik Enghusen Poulsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of 8-oxoguanosine (nmol/24h) (time frame: Change from Baseline after seven days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.