NCT01667692

Brief Summary

The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

8 months

First QC Date

August 12, 2012

Last Update Submit

August 15, 2012

Conditions

Keywords

H-pylorieradicationazithromycinclarithromycin

Outcome Measures

Primary Outcomes (1)

  • H-pylori cinfirmation

    confirmation is by endoscopy and biopsy

    1-3 months before study

Secondary Outcomes (2)

  • h-pylori eradication confirmation

    two months after completion of 14 days standard treatment

  • side effect of study srugs

    during 14 days standard treatment

Study Arms (2)

azithromycin

EXPERIMENTAL

Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics. It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.

Drug: azithromycin

clarithromycin

EXPERIMENTAL

Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.

Drug: clarithmycin

Interventions

Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics.\[1\] It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.

Also known as: (Zithromax, Azithrocin
azithromycin

Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.

Also known as: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...
clarithromycin

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy

You may not qualify if:

  • patients who got H-pylori eradication treatment previously
  • patients who used study drugs during 3months before study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behnam Baghianimoghadam

Yazd, Yazd Province, 8916863411, Iran

Location

MeSH Terms

Conditions

Peptic UlcerDyspepsia

Interventions

AzithromycinClarithromycin

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research consultant

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 17, 2012

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations