DyspepsiaPhase 3NCT02621359
A Two Week Nitazoxanidebased Quadruple Regimen
A Phase 3 study testing Nitazoxanide, Levofloxacin and Doxycyclin in people with Dyspepsia, run by Tanta University at 1 site in Egypt.
Trial summary
Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer. Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Nitazoxanide, Levofloxacin and Doxycyclin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with helicobacter infection.
- in whom the standard triple therapy (clarithromycin-based triple therapy) failed
Who cannot join
- Patients under 18 or over 65 years of age.
- Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
- pregnancy/lactation
- having contraindication or allergy to any of the study drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine dept.-Tanta university hospital
Tanta
Sherief Abd-Elsalam, lecturer, 00201095159522, Sherif_tropical@yahoo.com
About this study
Official title: A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.
Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .
However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.
Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .
Read the detailed description
Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.
Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.
- Conditions
- Dyspepsia
- Being tested
- Nitazoxanide, Levofloxacin, Doxycyclin, Omeprazole
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alenia, nitclean, parazoxanide
Nitazoxanide 500 mg twice daily
LevofloxacinDrug
Also called Tavanic, levoxin, venaxan.
Levofloxacin 500 mg once daily
DoxycyclinDrug
Also called Vibramycin, Doxymycin
Doxycyclin 100 mg twice daily
OmeprazoleDrug
Also called Omepak, Pepzole, Gasec, Risek.
Omeprazole 40 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Quadruple therapy | Experimental | Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days. Receives: Drug: Nitazoxanide; Drug: Levofloxacin; Drug: Doxycyclin; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with eradicated helicobacter
The total number of patients with eradicated helicobacter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Sherief Abd-Elsalam, lecturer, Principal investigator, Tropical medicine-Tanta university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621359
- Sponsor's protocol ID
- Quadruple therapy
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
- ClinicalTrials.gov ID
- NCT02621359
- Acronym / sponsor ID
- Quadruple therapy
- Conditions
- Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Dec 2015 (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.
Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.
Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .
However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.
Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .
Detailed description
Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.
Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadruple therapy | Experimental | Drug: Nitazoxanide, Drug: Levofloxacin, Drug: Doxycyclin, Drug: OmeprazoleNitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with helicobacter infection.
- in whom the standard triple therapy (clarithromycin-based triple therapy) failed
Key exclusion criteria (4 listed)
- Patients under 18 or over 65 years of age.
- Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
- pregnancy/lactation
- having contraindication or allergy to any of the study drugs
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 |
|---|---|---|
| NitazoxanideAlso: Alenia, nitclean, parazoxanideNitazoxanide 500 mg twice daily | Drug | Quadruple therapy |
| LevofloxacinAlso: Tavanic, levoxin, venaxan.Levofloxacin 500 mg once daily | Drug | Quadruple therapy |
| DoxycyclinAlso: Vibramycin, DoxymycinDoxycyclin 100 mg twice daily | Drug | Quadruple therapy |
| OmeprazoleAlso: Omepak, Pepzole, Gasec, Risek.Omeprazole 40 mg twice daily | Drug | Quadruple therapy |
Primary outcome
Number of patients with eradicated helicobacter
Time frame: 1 year
The total number of patients with eradicated helicobacter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
Sherief Abd-Elsalam, lecturer principal investigator
Tropical medicine-Tanta university hospital
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 Nitazoxanide, Levofloxacin and Doxycyclin in people with Dyspepsia, run by Tanta University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, lecturer (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with eradicated helicobacter (time frame: 1 year). 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 3 Jan 2018.