Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

NCT02785549 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2020-05-14

No results posted yet for this study

Summary

Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.

Conditions

  • Acute Diverticulitis

Interventions

DRUG

Ibuprofen

600 mg/8hours

DRUG

Acetaminophen

1 g/8 hours

DRUG

Amoxicillin/clavulanic acid

875mg/125mg/8 hours

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Neus Ruiz, MD · Corporacion Parc Tauli

  • Laura Mora, MD PhD · Corporacion Parc Tauli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-01-12
Completion
2020-04-01

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785549 on ClinicalTrials.gov