Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

NCT02376972 | Terminated Phase 2 DMC

• 1 other identifier: RFX-VAG/003/2012
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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

Conditions

BACTERIAL VAGINOSIS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS

  Day 22-30

• THERAPEUTIC CURE OF BACTERIAL VAGINOSIS

  Day 22-30

• MAINTENANCE OF CLINICAL CURE OF BACTERIAL VAGINOSIS

  Day 61-70

• MAINTENANCE OF BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS

  Day 61-70

• MAINTENANCE OF THERAPEUTIC CURE OF BACTERIAL VAGINOSIS

  60-69 DAYS AFTER THE FIRST DAY OF TREATMENT

Study Arms (4)

RIFAXIMIN VAGINAL TABLET 25 MG

EXPERIMENTAL

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

Drug: RIFAXIMIN VAGINAL TABLET 25 MG

RIFAXIMIN VAGINAL TABLET 100 MG

EXPERIMENTAL

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

Drug: RIFAXIMIN VAGINAL TABLET 100 MG

PLACEBO VAGINAL TABLET

PLACEBO COMPARATOR

PLACEBO VAGINAL TABLET ADMINISTERED ONCE A DAY FOR 5 DAYS

Drug: PLACEBO VAGINAL TABLET

METROGEL VAGINAL

ACTIVE COMPARATOR

METROGEL VAGINAL ADMINISTERED ONCE A DAY FOR 5 DAYS

Drug: METROGEL VAGINAL

Interventions

RIFAXIMIN VAGINAL TABLET 25 MG DRUG

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

RIFAXIMIN VAGINAL TABLET 25 MG

RIFAXIMIN VAGINAL TABLET 100 MG DRUG

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

RIFAXIMIN VAGINAL TABLET 100 MG

PLACEBO VAGINAL TABLET DRUG

PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY

PLACEBO VAGINAL TABLET

METROGEL VAGINAL DRUG

METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

METROGEL VAGINAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfasigma S.p.A.: lead
• Parexel: collaborator

Study Sites (1)

College of Medicine Drexel University

Philadelphia, Pennsylvania, 191012-1192, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Benchmarking

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Raffaella Tacchi, MD

  Alfasigma S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 3, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

US (1)