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Trial record 2 of 61 for:    Neomycin sulfate

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

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ClinicalTrials.gov Identifier: NCT00945334
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Mark Pimentel, MD, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Constipation-predominant Irritable Bowel Syndrome
Interventions Drug: Neomycin
Drug: Placebo
Drug: Rifaximin
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Placebo: placebo for 14 days tid

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Rifaximin: 550 mg po tid

Period Title: Overall Study
Started 19 18
Completed 16 15
Not Completed 3 3
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Placebo: placebo for 14 days tid

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Rifaximin: 550 mg po tid

Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
15
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
40.4  (14.3) 45.5  (16.9) 42.8  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
12
  75.0%
13
  86.7%
25
  80.6%
Male
4
  25.0%
2
  13.3%
6
  19.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16 15 31
1.Primary Outcome
Title Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
Hide Description

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).

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Placebo: placebo for 14 days tid

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Rifaximin: 550 mg po tid

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.2  (24.1) 28.6  (30.8)
2.Secondary Outcome
Title Change in Methane From Baseline
Hide Description

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.

Time Frame Baseline (Day 0) and Final Visit (Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
Change in breath test methane gas levels: baseline breath test minus final breath test measurement.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Placebo: placebo for 14 days tid

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Rifaximin: 550 mg po tid

Overall Number of Participants Analyzed 16 15
Median (Standard Deviation)
Unit of Measure: parts per million
7.5  (9.739557195) 15  (24.81324182)
Time Frame Immediately
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Placebo: placebo for 14 days tid

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Neomycin: 500 mg po bid for 14 days

Rifaximin: 550 mg po tid

All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      1/15 (6.67%)    
Ear and labyrinth disorders     
Tinnitus *  1/16 (6.25%)  1 0/15 (0.00%)  0
General disorders     
Unwell *  0/16 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark Pimentel
Organization: Cedars-Sinai Medical Center
Phone: 3104233792
Responsible Party: Mark Pimentel, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00945334     History of Changes
Other Study ID Numbers: 18709
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: February 25, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015