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Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome (C-IBS)

This study has been completed.
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Mark Pimentel, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00945334
First received: July 23, 2009
Last updated: July 17, 2015
Last verified: July 2015

July 23, 2009
July 17, 2015
August 2009
June 2013   (final data collection date for primary outcome measure)
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Visual analog scale (VAS) score for constipation:

Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).

to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00945334 on ClinicalTrials.gov Archive Site
Change in Methane From Baseline [ Time Frame: Baseline (Day 0) and Final Visit (Day 44) ] [ Designated as safety issue: No ]

Methane output was reported as methane in parts per million (ppm) on breath test:

Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration.

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Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Constipation-predominant Irritable Bowel Syndrome
  • Drug: Neomycin
    500 mg po bid for 14 days
    Other Names:
    • Mycifradin
    • Neo-Tab
    • Neo-Fradin
  • Drug: Placebo
    placebo for 14 days tid
  • Drug: Rifaximin
    550 mg po tid
    Other Name: Xifaxan
  • Experimental: Group 1
    Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
    Interventions:
    • Drug: Neomycin
    • Drug: Placebo
  • Experimental: Group 2
    Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
    Interventions:
    • Drug: Neomycin
    • Drug: Rifaximin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rome III positive IBS subjects (18-75 years of age)
  • Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.
  • Presence of detectable methane on single breath sample (≥ 3ppm).
  • If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.

Exclusion Criteria:

  • Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
  • Recent antibiotic use (within the last 30 days)
  • Subjects with known pelvic floor dysfunction
  • Pregnancy
  • Creatinine level > 1.4
  • Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
  • Subjects with hearing loss and/or tinnitus
  • History of bowel obstruction
  • History of celiac disease
  • History of inflammatory bowel disease
  • Cirrhosis
  • Diabetes
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00945334
18709
Yes
Not Provided
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Mark Pimentel, MD, Cedars-Sinai Medical Center
Mark Pimentel, MD
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Mark Pimentel, MD, FRCP(C) Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP