A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis

Last updated: December 19, 2017
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Trial Status Unknown

Phase

4

Condition

Appendicitis

Treatment

N/A

Clinical Study ID

NCT03380793
HS-10090-402
  • Ages 18-65
  • All Genders

Study Summary

To assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 and 65 years old

  • A diagnosis of suppurative or gangrenous appendicitis based on:

  1. metastatic right lower abdominal pain

  2. lower abdominal tenderness and/or rebound tenderness

  3. pyrexia (axillary temperature ≥ 37.5 °C), a WBC > 10*109/L on routine bloodexamination

  4. Voluntary signing of written informed consent

Exclusion

Exclusion Criteria:

  • patients with an allergy to nitroimidazole

  • patients with a history of antibiotic therapy within the last 48 hours

  • patients with any condition likely to require broad spectrum antibiotics

  • patients who can not evaluate the efficacy or difficult to complete the desired courseof treatment

  • ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN

  • patients with severe systemic diseases likely to affect therapy (e.g., cardiovascularabnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)

  • patients with other diseases or use other drugs which may interfere with the efficacyor safety of the drug

  • patients who participated other clinical trials within 6 months before the start ofthe trial

  • Pregnant women, breastfeeding women, women of childbearing age without effectivecontraceptive

Study Design

Total Participants: 614
Study Start date:
September 01, 2016
Estimated Completion Date:
October 31, 2018

Study Description

Acute appendicitis is among the most common cause of acute abdominal pain. In patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. Metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. The sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. Antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. Morinidazole, a National Class I Antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole.

Morinidazole and Sodium Chloride Injection used in pelvic inflammatory disease or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole in patients with suppurative or gangrenous appendicitis.

Connect with a study center

  • PLA General Hospital

    Beijing, 100853
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.