Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

NCT ID: NCT02376972

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-02-29

Brief Summary

THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS

Detailed Description

THIS IS A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY PLANNING TO ENROL 626 SUBJECTS AFFECTED BY BACTERIAL VAGINOSIS.

PRIMARY ENDPOINT:

TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS

SECONDARY ENDPOINT:

TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS METROGEL VAGINAL IN SUBJECTS WITH BACTERIAL VAGINOSIS.

Conditions

BACTERIAL VAGINOSIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RIFAXIMIN VAGINAL TABLET 25 MG

RIFAXIMIN VAGINAL TABLET 25 MG ADMINISTERED ONCE A DAY FOR 5 DAYS

Group Type: EXPERIMENTAL

RIFAXIMIN VAGINAL TABLET 25 MG

Intervention Type: DRUG

RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY

RIFAXIMIN VAGINAL TABLET 100 MG

RIFAXIMIN VAGINAL TABLET 100 MG ADMINISTERED ONCE A DAY FOR 5 DAYS

Group Type: EXPERIMENTAL

RIFAXIMIN VAGINAL TABLET 100 MG

Intervention Type: DRUG

RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY

PLACEBO VAGINAL TABLET

PLACEBO VAGINAL TABLET ADMINISTERED ONCE A DAY FOR 5 DAYS

Group Type: PLACEBO_COMPARATOR

PLACEBO VAGINAL TABLET

Intervention Type: DRUG

PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY

METROGEL VAGINAL

METROGEL VAGINAL ADMINISTERED ONCE A DAY FOR 5 DAYS

Group Type: ACTIVE_COMPARATOR

METROGEL VAGINAL

Intervention Type: DRUG

METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

Interventions

RIFAXIMIN VAGINAL TABLET 25 MG

RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY

Intervention Type: DRUG

RIFAXIMIN VAGINAL TABLET 100 MG

RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY

Intervention Type: DRUG

PLACEBO VAGINAL TABLET

PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY

Intervention Type: DRUG

METROGEL VAGINAL

METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of bacterial vaginosis with Amsel's criteria (4 out of 4 fulfilled criteria):

• Off white (milky or gray), thin, homogeneous, adherent vaginal discharge
• pH >4.5
• Positive "whiff test"
• Presence of clue cells ≥20%
• Bacteriological diagnosis of bacterial vaginosis with Gram stain Nugent score ≥ 4 (patients may be enrolled/randomized without this result)
• Post-menarchal, pre-menopausal female patient
• Non-pregnant (negative urine pregnancy test at Entry Visit/V1) nor breast-feeding patient
• Patient aged between 18 50 years, inclusively
• Patient who is willing to be asked questions about personal medical health and sexual history
• Patient capable of and willing to conform to the study protocol
• Patient who have been thoroughly informed of the aim of the study and the study procedures and who provided signed and dated written informed consent form
• Patient who agrees to abstain from intercourse during the 5 day treatment period
• Patient who agrees also to abstain from intercourse 3 days before the scheduled visits of follow-up
• Patient who agrees to abstain from the use of any other intravaginal product (i.e., douching, feminine deodorants sprays, tampons, spermicides, gels, foams, vaginal birth control ring and diaphragms) during the entire study period
• Patient who agrees to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of bilateral tubal ligation, male partner with a vasectomy, a hormonal contraceptive [oral, patch, injectable or implantable (excluding intrauterine implantable devices [IUD], intrauterine system [IUS] and vaginal rings), or abstinence
• Patient who agrees to abstain from alcohol ingestion during the 5-day treatment period and for 1 day afterward

Exclusion Criteria

• Virginity
• Patient with other infectious causes of vulvovaginitis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex lesions, or Human Papilloma Virus lesions); patients may be enrolled/randomized without these results)
• Other vulvovaginal or cervical conditions, abnormalities or disorders confounding the interpretation of clinical response (including total hysterectomy)
• Symptoms suggestive of pelvic inflammatory disease
• Patient with intra uterine device (IUD), intrauterine system (IUS), or vaginal ring as contraceptive method
• Patient with severe hepatic insufficiency (Child C)
• Patient with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 - 4)
• Patient who will be being evaluated, including colposcopy and cervical biopsies, or being treated during the study period, for abnormal Pap test or cervical carcinoma. To note that if the Pap test will be performed at baseline, the result will be known after the randomization visit: patients may be enrolled without this result
• Any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, immunological (including HIV infection), hematological or neoplastic disease (including all cervical neoplastic diseases)
• Cervical cryotherapy, loop electrosurgical excision (LEEP), cervical laser, or any other ablative or excisional cervical procedures within the last 3 months
• Vaginal laser within the last 3 months
• Patient with clinically relevant pathological laboratory values
• Known hypersensitivity to rifaximin
• Known hypersensitivity to excipients present in rifaximin, placebo or metronidazole formulations
• Known hypersensitivity to metronidazole, either orally or topically administered, or any forms of parabens
• Concurrent anticoagulant therapy with coumadin or warfarin
• Menstruating or anticipated menstruation/withdrawal bleed at Entry Visit/V1 and during the drug administration
• Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization
• Patient who have participated in another clinical trial or have taken an investigational drug within the last 4 weeks prior screening
• Patient who has taken disulfuram within the last 14 days
• Withdrawal of informed consent
• Patient previously randomized in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Alfasigma S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raffaella Tacchi, MD

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

College of Medicine Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

RFX-VAG/003/2012

Identifier Type: -

Identifier Source: org_study_id