Status:
UNKNOWN
A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Appendicitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 gang...
Detailed 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. Metronidaz...
Eligibility Criteria
Inclusion
- 18 and 65 years old
- A diagnosis of suppurative or gangrenous appendicitis based on:
- metastatic right lower abdominal pain
- lower abdominal tenderness and/or rebound tenderness
- pyrexia (axillary temperature ≥ 37.5 °C), a WBC \> 10\*109/L on routine blood examination
- Voluntary signing of written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT03380793
Start Date
September 1 2016
End Date
October 1 2018
Last Update
December 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PLA General Hospital
Beijing, China, 100853