Helicobacter Pylori InfectionPhase 3RCTNCT05863858
Eradication of H. Pylori Infection With Moxifloxacin
A Phase 3 study testing Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID and Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID in people with Helicobacter Pylori Infection and Helicobacter Pylori Infection, Susceptibility to, run by Iyad Naeem Muhammad, PhD at 1 site in Pakistan.
Trial summary
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to
- What is being tested?
- Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID and Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2020to 8 Jun 2022
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful isolation of H. pylori from the patient, and
- patients of at least 18 years of age.
Who cannot join
- age under 18 years
- presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
- previous gastric surgery,
- allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
Read the detailed description
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
- Being tested
- Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID, Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
- Keywords
- Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BIDDrug
Also called Levofloxacin, Amoxicillin, Omeprazole, Tinidazole
The eradication rate of H. Pylori with levofloxacin-based sequential therapy
Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBIDDrug
Also called Moxifloxacin, Amoxicillin, Omeprazole
The eradication rate of H. Pylori with moxifloxacin-based triple therapy
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin-based sequential Therapy | Active comparator | 1. Tablets Levofloxacin 500mg BID for the first five days
2. Tablet Amoxicillin 1 gm BID for first five days
3. Capsules Omeprazole 20 mg BID for first five days followed by
1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days
Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms Receives: Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID |
| Moxifloxacin-based Triple Therapy | Active comparator | 1. Tablet Moxifloxacin 400 mg OD for ten days
2. Tablet Amoxicillin 1 gm BID for ten days
3. Capsule Omeprazole 20 mg BID for ten days
Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance. Receives: Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori status one month after treatment.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
Measured: One month after finishing with therapy.
Secondary outcomes (2)
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance
Measured: One month after finishing with therapy.
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities).
Measured: One month after finishing with therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jun 2020
- Primary completion1 Dec 2021
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into two regimens: 1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or 2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iyad Naeem Muhammad, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iyad Naeem Muhammad, PhD, University of Karachi
- Investigators
- Iyad N Muhammad, Ph.D., Principal investigator, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863858
- Sponsor's protocol ID
- RCT-HP-01
- Acronym
- RCT
- Status last verified
- May 2023
- First submitted
- 25 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared and made available for other researchers after due coding. The data will be summarized and tabulated in the thesis and article manuscripts. The IPD would include the basic information and demographic data, the treatment protocols, informed consent, and the outcome measures data.
Publications
Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24.
PubMed 25547786Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733.
PubMed 32351290Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC; Taiwan Acid-related Disease, Microbiota (TARD-M) Consortium. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter. 2021 Oct;26(5):e12840. doi: 10.1111/hel.12840. Epub 2021 Aug 12.
PubMed 34390083Hwang JJ, Lee DH, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234.
PubMed 26401089
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT05863858
- Acronym / sponsor ID
- RCT / RCT-HP-01
- Keywords
- Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Iyad Naeem Muhammad, PhDUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 18 May 2023 (actual)
- 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 main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
Detailed description
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized into two regimens: 1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or 2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin-based sequential Therapy | Active comparator | Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID1. Tablets Levofloxacin 500mg BID for the first five days 2. Tablet Amoxicillin 1 gm BID for first five days 3. Capsules Omeprazole 20 mg BID for first five days followed by 1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms |
| Moxifloxacin-based Triple Therapy | Active comparator | Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID1. Tablet Moxifloxacin 400 mg OD for ten days 2. Tablet Amoxicillin 1 gm BID for ten days 3. Capsule Omeprazole 20 mg BID for ten days Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Successful isolation of H. pylori from the patient, and
- patients of at least 18 years of age.
Key exclusion criteria (4 listed)
- age under 18 years
- presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
- previous gastric surgery,
- allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
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 |
|---|---|---|
| Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BIDAlso: Levofloxacin, Amoxicillin, Omeprazole, TinidazoleThe eradication rate of H. Pylori with levofloxacin-based sequential therapy | Drug | Levofloxacin-based sequential Therapy |
| Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBIDAlso: Moxifloxacin, Amoxicillin, OmeprazoleThe eradication rate of H. Pylori with moxifloxacin-based triple therapy | Drug | Moxifloxacin-based Triple Therapy |
Primary outcome
Helicobacter pylori status one month after treatment.
Time frame: One month after finishing with therapy.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
2 secondary outcomes
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Time frame: One month after finishing with therapy.
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Time frame: One month after finishing with therapy.
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 18 May 2023.
- Background: PubMed 25547786Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24.
- Background: PubMed 32351290Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733.
- Background: PubMed 34390083Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC; Taiwan Acid-related Disease, Microbiota (TARD-M) Consortium. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter. 2021 Oct;26(5):e12840. doi: 10.1111/hel.12840. Epub 2021 Aug 12.
- Background: PubMed 26401089Hwang JJ, Lee DH, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234.
- Individual participant dataSharing planned: Yes. IPD will be shared and made available for other researchers after due coding. The data will be summarized and tabulated in the thesis and article manuscripts. The IPD would include the basic information and demographic data, the treatment protocols, informed consent, and the outcome measures data.
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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.
Iyad N Muhammad, Ph.D. principal investigator
Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID and Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID in people with Helicobacter Pylori Infection and Helicobacter Pylori Infection, Susceptibility to, run by Iyad Naeem Muhammad, PhD at 1 site in Pakistan.
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 2 inclusion and 4 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 18 May 2023. 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 Pakistan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Helicobacter pylori status one month after treatment. (time frame: One month after finishing with therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863858, which also lists 4 linked publications.
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 18 May 2023.