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

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Criteria

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