Peptic UlcerPhase 4H-pyloriNCT01667692
Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
A Phase 4 study testing azithromycin and clarithmycin in people with Peptic Ulcer and Dyspepsia, run by Shahid Sadoughi University of Medical Sciences and Health Services at 1 site in Iran.
Trial summary
The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Peptic Ulcer, Dyspepsia, H-pylori
- What is being tested?
- azithromycin and clarithmycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Mar 2012
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy
Who cannot join
- patients who got H-pylori eradication treatment previously
- patients who used study drugs during 3months before study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen
The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.
Read the detailed description
Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not available.
HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it is not available in underdevelopment countries.
There are different articles about replacement clarithromycin with azithromycin as a method of eradication of HP that is decreases length of therapy and increases, effectiveness of drugs and decreases resistance of drugs.
The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.
- Conditions
- Peptic Ulcer, Dyspepsia, H-pylori
- Being tested
- azithromycin, clarithmycin
- Keywords
- H-pylori, eradication, azithromycin, clarithromycin
- Medical subject headings
- Peptic Ulcer, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called (Zithromax, Azithrocin
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.
clarithmycinDrug
Also called Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: clarithmycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-pylori cinfirmation
confirmation is by endoscopy and biopsy
Measured: 1-3 months before study
Secondary outcomes (2)
h-pylori eradication confirmation
confirmation of eradication was by endoscopy and biopsy
Measured: two months after completion of 14 days standard treatment
side effect of study srugs
it was assessed by researcher and self report of patients. variables like nausea, vomiting and diarrhea. the prevalence of each treatment related complain was registered by taking history from patients.
Measured: during 14 days standard treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Sadoughi University of Medical Sciences and Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667692
- Sponsor's protocol ID
- ssu.hakimi-89027
- Acronym
- H-pylori
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen
- ClinicalTrials.gov ID
- NCT01667692
- Acronym / sponsor ID
- H-pylori / ssu.hakimi-89027
- Conditions
- Peptic Ulcer, Dyspepsia, H-pylori
- Keywords
- H-pylori, eradication, azithromycin, clarithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shahid Sadoughi University of Medical Sciences and Health ServicesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Aug 2012 (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 Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.
Detailed description
Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not available.
HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it is not available in underdevelopment countries.
There are different articles about replacement clarithromycin with azithromycin as a method of eradication of HP that is decreases length of therapy and increases, effectiveness of drugs and decreases resistance of drugs.
The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin | Experimental | Drug: azithromycinAzithromycin (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. |
| clarithromycin | Experimental | Drug: clarithmycinClarithromycin 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy
Key exclusion criteria (2 listed)
- patients who got H-pylori eradication treatment previously
- patients who used study drugs during 3months before study
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 |
|---|---|---|
| azithromycinAlso: (Zithromax, AzithrocinAzithromycin (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. | Drug | azithromycin |
| clarithmycinAlso: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...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 | clarithromycin |
Primary outcome
H-pylori cinfirmation
Time frame: 1-3 months before study
confirmation is by endoscopy and biopsy
2 secondary outcomes
h-pylori eradication confirmation
Time frame: two months after completion of 14 days standard treatment
side effect of study srugs
Time frame: during 14 days standard treatment
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 17 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing azithromycin and clarithmycin in people with Peptic Ulcer and Dyspepsia, run by Shahid Sadoughi University of Medical Sciences and Health Services at 1 site in Iran.
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 1 inclusion and 2 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 17 Aug 2012. 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 Iran. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
H-pylori cinfirmation (time frame: 1-3 months before study). 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 17 Aug 2012.