Pentriox - Induction of Oxidative Stress | NCT02188472

Studies
Pentriox - Induction of Oxidative Stress

NCT02188472

Sponsor

Henrik Enghusen Poulsen

Status

Completed

Last Update Posted

Jul 11, 2014Estimated

Enrollment

90Actual

Phase

Phase 1

Conditions

Oxidative Stress

Interventions

Penicillin V
Trimethoprim
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Nov 1, 2010

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2014

Last Update Posted Date

Jul 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henrik Enghusen Poulsen, Professor, Rigshospitalet, DenmarkSponsor-Investigator

Lead Sponsor

Henrik Enghusen PoulsenOTHER

Collaborators

Name	Class
Klinisk Biokemisk Afdeling	UNKNOWN
Klinisk farmakologisk Afdeling	UNKNOWN
Sektion for Biomedicin Institut for Veterinær Patobiologi	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Penicillin V	Active Comparator	Penicillin V 2 tablets of 330 mg twice dayly for 7 days	Drug: Penicillin V
Trimethoprim	Active Comparator	2 Tablet Trimethoprim of 100 mg twice daily for 7 days	Drug: Trimethoprim
Placebo	Placebo Comparator	2 Placebo Tablets twice daily for 7 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Penicillin V	Drug	Penicillin V: 2 x 330mg tablets should be taken twice daily	Penicillin V

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary excretion of 8-oxoguanosine (nmol/24h)		Change from Baseline after seven days of treatment
Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)		Change from Baseline after seven days of treatment

Secondary Outcomes

Measure	Description	Time Frame
Malondialdehyde		At the screening visit and at the final visit

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik E Poulsen, MD	Department head	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology		Copenhagen		2100	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D010404	Penicillin V
D014295	Trimethoprim

Ancestor Terms

ID	Term
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

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Browse Branches

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