check_circleStudy Completed

Pelvic Inflammatory Disease

Bayer Identifier:

10995

ClinicalTrials.gov Identifier:

NCT00683865

EudraCT Number:

Not Available

EU CT Number:

Not Available
Uncomplicated pelvic inflammatory disease. Treatment with Moxifloxacin.

Trial purpose

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Key Participants Requirements

Sex

Female

Age

18 Years
  • - 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
  • - Pregnancy
    - Abnormal lab values

Trial summary

Enrollment Goal
749
Trial Dates
April 2003 - October 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Odense C, DK-5000, Denmark
Completed
PARIS, 75020, France
Completed
ATHENS, 115 28, Greece
Completed
Pavia, 27100, Italy
Completed
Vilnius, LT-2043, Lithuania
Completed
Bloemfontein, 9300, South Africa
Completed
Rostock, 18057, Germany
Completed
Hvidovre, 2650, Denmark
Completed
Kotka, 48210, Finland
Completed
CRETEIL CEDEX, 94010, France
Terminated
London, WC1E 6AU, United Kingdom
Completed
Athens, 115 21, Greece
Completed
Vilnius, LT-2021, Lithuania
Completed
Trollhättan, 461 85, Sweden
Completed
Mamelodi, 0122, South Africa
Completed
Leverkusen, 51375, Germany
Completed
Helsinki, 00029, Finland
Completed
Birmingham, B4 6DH, United Kingdom
Completed
Budapest, 1115, Hungary
Completed
Kraków, 30-501, Poland
Completed
Moscow, 117415, Russia
Completed
Lund, 221 85, Sweden
Completed
Budapest, H-1085, Hungary
Completed
Trieste, 34137, Italy
Terminated
Warsaw, PL-00-909, Poland
Completed
Moscow, 107076, Russia
Completed
Grevenbroich, 41515, Germany
Terminated
Roskilde, DK-4000, Denmark
Terminated
Hämeenlinna, 13530, Finland
Terminated
London, SW10 9NH, United Kingdom
Terminated
Perugia, 06126, Italy
Completed
MONTPELLIER, 34059, France
Completed
IOANNINA, 455 00, Greece
Completed
Eger, 3300, Hungary
Completed
Lublin, 20-090, Poland
Completed
Berlin, 10117, Germany
Completed
Kecskemet, 6000, Hungary
Completed
Poznan, 60-535, Poland
Completed
Varberg, 432 81, Sweden
Completed
Cape Town, 7925, South Africa
Terminated
Athens, 115 21, Greece
Terminated
Gyor, 9002, Hungary
Terminated
Göteborg, 413 45, Sweden
Terminated
Berlin, 10249, Germany
Terminated
MONTAUBAN, 82000, France
Terminated
Bristol, BS2 8HW, United Kingdom
Terminated
LILLE, 59037, France
Completed
Southampton, SO14 0YG, United Kingdom
Completed
Vilnius, LT-2000, Lithuania
Completed
Moscow, 117049, Russia
Terminated
Linköping, 581 85, Sweden
Completed
Cape Town, 7505, South Africa
Terminated
Joensuu, 80210, Finland
Completed
BRIVE-LA-GAILLARDE, 19100, France
Terminated
Nottingham, NG5 1PB, United Kingdom
Completed
Klaipeda, LT-5808, Lithuania
Completed
München, 80337, Germany
Terminated
TOULOUSE, 31059, France
Completed
London, SW17 0QT, United Kingdom
Completed
Bialystok, 15-276, Poland
Completed
Soweto, 1804, South Africa
Terminated
IOANNINA, 455 00, Greece
Completed
Lodz, 93-338, Poland
Completed
Pretoria, South Africa
Completed
Wuppertal, 42103, Germany
Terminated
IOANNINA, 455 00, Greece
Completed
Durban, 4001, South Africa
Terminated
COLOMBES CEDEX, 92701, France
Completed
MURET, 31600, France
Completed
DOMONT, 95330, France
Completed
ANTONY CEDEX, 92166, France
Completed
Johannesburg, 2132, South Africa
Completed
Essen, 45257, Germany
Terminated
Warszawa, 00-416, Poland
Terminated
NANCY CEDEX, 54045, France
Completed
Bialystok, 15-276, Poland
Completed
BORDEAUX, 33000, France
Terminated
Otwock, 05-400, Poland
Completed
PARIS, 75009, France
Completed
BEAUMONT, 63110, France
Completed
CENON, 33150, France
Terminated
Denmark
Terminated
Greece
Terminated
Hungary
Terminated
Greece
Terminated
United Kingdom
Terminated
Greece
Terminated
Poland

Primary Outcome

  • Clinical response 5 to 24 days after the last dose of study medication
    date_rangeTime Frame:
    5 to 24 days after the last dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
    date_rangeTime Frame:
    visit 28 to 42 days after last dose
    enhanced_encryption
    Safety Issue:
    no
  • Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
    date_rangeTime Frame:
    (Day 4-7) and at follow-up 28 to 42 days after last dose
    enhanced_encryption
    Safety Issue:
    no
  • Reduction from baseline in pain report at the different assessment visits
    date_rangeTime Frame:
    Over the entire trial period (overall)
    enhanced_encryption
    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
    date_rangeTime Frame:
    Over the entire trial period (overall)
    enhanced_encryption
    Safety Issue:
    no

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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