Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

BACTERIAL VAGINOSIS Clinical Trial

— VARIANT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02376972
• Other study ID #: RFX-VAG/003/2012
• Status: Terminated
• Phase: Phase 2
• First received: February 19, 2015
• Last updated: October 7, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Alfa Wassermann S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 392
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• BACTERIAL VAGINOSIS
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• RIFAXIMIN VAGINAL TABLET 25 MG
RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY
• RIFAXIMIN VAGINAL TABLET 100 MG
RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY
• PLACEBO VAGINAL TABLET
PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY
• METROGEL VAGINAL
METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

Locations

Country	Name	City	State
United States	College of Medicine Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alfa Wassermann S.p.A.	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLINICAL CURE OF BACTERIAL VAGINOSIS	RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA, I.E. NORMAL PHYSIOLOGICAL DISCHARGE, NEGATIVE "WHIFF TEST", CLUE CELLS >20%	Day 22-30	No
Secondary	BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS	GRAM STAIN NUGENT SCORE <4	Day 22-30	No
Secondary	THERAPEUTIC CURE OF BACTERIAL VAGINOSIS	AMSEL'S CRITERIA AND GRAM STAIN NUGENT (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)	Day 22-30	No
Secondary	MAINTENANCE OF CLINICAL CURE OF BACTERIAL VAGINOSIS	AMSEL'S CRITERIA (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA)	Day 61-70	No
Secondary	MAINTENANCE OF BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS	NUGENT SCORE <4	Day 61-70	No
Secondary	MAINTENANCE OF THERAPEUTIC CURE OF BACTERIAL VAGINOSIS	AMSEL'S CRITERIA AND NUGENT SCORE (MAINTENANCE OF RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)	60-69 DAYS AFTER THE FIRST DAY OF TREATMENT	No
Secondary	NUMBER, INTENSITY AND TYPE OF ADVERSE EVENTS	The incidence of adverse events to be summarized by body system and MedDRA preferred term.	Up to Day 70	Yes
Secondary	LOCAL OBJECTIVE TOLERABILITY	Vaginal mucosa status in terms of erythema (score 0 to 3), edema (score 0 to 3), pethechial hemorrhages (absence/presence), ulcers (absence/presence)	Day 22-30	Yes
Secondary	LOCAL SUBJECTIVE TOLERABILITY	Grade (from 0 to 4) of vaginal itching, pain and burning	Day 1 to Day 5	Yes