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Uncomplicated Pelvic Inflammatory Disease; Treatment With Moxifloxacin. (MAIDEN)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00683865
First received: May 21, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  Purpose

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease


Condition Intervention Phase
Pelvic Inflammatory Disease
 Drug: Ofloxacin
Drug: Avelox (Moxifloxacin, BAY12-8039)
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical response 5 to 24 days after the last dose of study medication [ Time Frame: 5 to 24 days after the last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication [ Time Frame: visit 28 to 42 days after last dose ] [ Designated as safety issue: No ]
  • Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose [ Time Frame: (Day 4-7) and at follow-up 28 to 42 days after last dose ] [ Designated as safety issue: No ]
  • Reduction from baseline in pain report at the different assessment visits [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]
  • Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]

Enrollment: 632
Study Start Date: April 2003
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Ofloxacin
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Experimental: Arm 2 Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg po od for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683865

  Show 77 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00683865     History of Changes
Other Study ID Numbers: 10995
Study First Received: May 21, 2008
Last Updated: June 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Ethics Committee
Finland: Ethics Committee
France: Ministry of Health
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Sweden: Regional Ethical Review Board
South Africa: National Health Research Ethics Council
Russia: Ethics Committee

Keywords provided by Bayer:
Antibiotic treatment
Pelvic infection
Interventional study
Female

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female
Metronidazole
Moxifloxacin
Ofloxacin
Norgestimate, ethinyl estradiol drug combination
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013