ClinicalTrials.gg
RecruitingNCT04161768Updated Nov 13, 2019

Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

A Phase 3 interventional study of Norfloxacin and Itopride in Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Tanta University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Dec 2018, registered Nov 2019).
  • Started Dec 2018; still recruiting 7 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study summary

Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Read the detailed description

Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

02

Conditions studied

  • Spontaneous Bacterial Peritonitis

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03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's planned enrollment of 80 is close to the median of 79 across 106 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • cirrhotic patients with ascites who had previous episodes of SBP.

Exclusion criteria

Exclusion Criteria:

    1. Allergy or for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Norfloxacin

    Norfloxacin 400 mg daily

    Drug: Norfloxacin

  • Experimental
    Norfloxacin and Itopride

    Norfloxacin 400 mg daily and Itopride 50 mg three times daily.

    Drug: Norfloxacin · Drug: Itopride

Interventions

  • Norfloxacin 400 mg daily

    Also known as: Epinor

  • Itopride 50 mg three times daily

    Also known as: Ganaton

06

What researchers measure

Primary outcomes

  1. Number of bouts of recurrence during treatment.

    The recurrence of infection during treatment.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04161768
Lead sponsor
Tanta University
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Principal investigator
First posted
Nov 13, 2019
Start date
Dec 1, 2018
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Nov 13, 2019

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
sherief abd-elsalam, ass. prof.
Contact
sherif_tropical@yahoo.com
00201147773440
Afaf Younes Mohammed Younes, Msc
principal investigator · Tanta University - Faculty of Medicine
Mona Ahmed Helmy Shehata, Prof.
principal investigator · Tanta University - Faculty of Medicine
Sherief Abd-Elsalam, Ass. Prof.
principal investigator · Tanta University - Tropical Medicine Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Itopride

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