Expired Study
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Philadelphia, Pennsylvania


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

RFX-VAG/003/2012


NCT ID:

NCT02376972


Secondary ID:


Study Acronym:

VARIANT


Brief Title:

Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis


Official Title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rifaximin Vaginal Tablets in the Treatment of Bacterial Vaginosis


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alfa Wassermann S.p.A.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

According to the Recommendation of the Indip


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

392


Enrollment Type:

Actual


Overall Contact Information

Official Name:Raffaella Tacchi, MD
Study Director
Alfa Wassermann S.p.A.

Study Dates

Start Date:April 2015
Completion Date:February 2016
Completion Type:Actual
Primary Completion Date:February 2016
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 7, 2016
First Received Date:February 19, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:LOCAL SUBJECTIVE TOLERABILITY
Time Frame:Day 1 to Day 5
Safety Issues:True
Description:Grade (from 0 to 4) of vaginal itching, pain and burning
Outcome Type:Secondary Outcome
Measure:LOCAL OBJECTIVE TOLERABILITY
Time Frame:Day 22-30
Safety Issues:True
Description:Vaginal mucosa status in terms of erythema (score 0 to 3), edema (score 0 to 3), pethechial hemorrhages (absence/presence), ulcers (absence/presence)
Outcome Type:Secondary Outcome
Measure:NUMBER, INTENSITY AND TYPE OF ADVERSE EVENTS
Time Frame:Up to Day 70
Safety Issues:True
Description:The incidence of adverse events to be summarized by body system and MedDRA preferred term.
Outcome Type:Secondary Outcome
Measure:MAINTENANCE OF THERAPEUTIC CURE OF BACTERIAL VAGINOSIS
Time Frame:60-69 DAYS AFTER THE FIRST DAY OF TREATMENT
Safety Issues:False
Description:AMSEL'S CRITERIA AND NUGENT SCORE (MAINTENANCE OF RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)
Outcome Type:Secondary Outcome
Measure:MAINTENANCE OF BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS
Time Frame:Day 61-70
Safety Issues:False
Description:NUGENT SCORE <4
Outcome Type:Secondary Outcome
Measure:MAINTENANCE OF CLINICAL CURE OF BACTERIAL VAGINOSIS
Time Frame:Day 61-70
Safety Issues:False
Description:AMSEL'S CRITERIA (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA)
Outcome Type:Secondary Outcome
Measure:THERAPEUTIC CURE OF BACTERIAL VAGINOSIS
Time Frame:Day 22-30
Safety Issues:False
Description:AMSEL'S CRITERIA AND GRAM STAIN NUGENT (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)
Outcome Type:Secondary Outcome
Measure:BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS
Time Frame:Day 22-30
Safety Issues:False
Description:GRAM STAIN NUGENT SCORE <4
Outcome Type:Primary Outcome
Measure:CLINICAL CURE OF BACTERIAL VAGINOSIS
Time Frame:Day 22-30
Safety Issues:False
Description:RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA, I.E. NORMAL PHYSIOLOGICAL DISCHARGE, NEGATIVE "WHIFF TEST", CLUE CELLS >20%

Study Interventions

Intervention Type:Drug
Name:RIFAXIMIN VAGINAL TABLET 25 MG
Description:RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY
Arm Name:RIFAXIMIN VAGINAL TABLET 25 MG
Intervention Type:Drug
Name:RIFAXIMIN VAGINAL TABLET 100 MG
Description:RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY
Arm Name:RIFAXIMIN VAGINAL TABLET 100 MG
Intervention Type:Drug
Name:PLACEBO VAGINAL TABLET
Description:PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY
Arm Name:PLACEBO VAGINAL TABLET
Intervention Type:Drug
Name:METROGEL VAGINAL
Description:METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY
Arm Name:METROGEL VAGINAL

Study Arms

Study Arm Type:Active Comparator
Arm Name:METROGEL VAGINAL
Description:METROGEL VAGINAL ADMINISTERED ONCE A DAY FOR 5 DAYS
Study Arm Type:Placebo Comparator
Arm Name:PLACEBO VAGINAL TABLET
Description:PLACEBO VAGINAL TABLET ADMINISTERED ONCE A DAY FOR 5 DAYS
Study Arm Type:Experimental
Arm Name:RIFAXIMIN VAGINAL TABLET 100 MG
Description:RIFAXIMIN VAGINAL TABLET 100 MG ADMINISTERED ONCE A DAY FOR 5 DAYS
Study Arm Type:Experimental
Arm Name:RIFAXIMIN VAGINAL TABLET 25 MG
Description:RIFAXIMIN VAGINAL TABLET 25 MG ADMINISTERED ONCE A DAY FOR 5 DAYS

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alfa Wassermann S.p.A.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Parexel

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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