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

NCT ID: NCT03380793

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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morinidazole

morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Group Type EXPERIMENTAL

morinidazole

Intervention Type DRUG

morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Interventions

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morinidazole

morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Intervention Type DRUG

Eligibility Criteria

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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 blood examination
4. Voluntary signing of written informed consent

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 course of 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., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
* patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
* patients who participated other clinical trials within 6 months before the start of the trial
* Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Tang

Role: CONTACT

Phone: 13701393663

Facility Contacts

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Yun Tang

Role: primary

Other Identifiers

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HS-10090-402

Identifier Type: -

Identifier Source: org_study_id