Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Pelvic Inflammatory Disease Clinical Trial

— MAIDEN  

Official title:

Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683865
• Other study ID #: 10995
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2008
• Last updated: October 12, 2014
• Start date: April 2003
• Est. completion date: October 2004

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Ethics CommitteeFinland: Ethics CommitteeFrance: Ministry of HealthGreece: Ethics CommitteeHungary: National Institute of PharmacyItaly: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthSweden: Regional Ethical Review BoardSouth Africa: National Health Research Ethics CouncilRussia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;

• Adnexal tenderness on bimanual vaginal examination,

• Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);

• Signed PIC/IC

Exclusion Criteria:

• Pregnancy

• Abnormal lab values

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease

Intervention

Drug:
• Ofloxacin
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
• Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg po od for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Lithuania,  Poland,  Russian Federation,  South Africa,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response 5 to 24 days after the last dose of study medication		5 to 24 days after the last dose	No
Secondary	Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication		visit 28 to 42 days after last dose	No
Secondary	Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose		(Day 4-7) and at follow-up 28 to 42 days after last dose	No
Secondary	Reduction from baseline in pain report at the different assessment visits		Over the entire trial period (overall)	No
Secondary	Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up		Over the entire trial period (overall)	No

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