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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
Results First Received: February 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Constipation-predominant Irritable Bowel Syndrome
Interventions: Drug: Neomycin
Drug: Placebo
Drug: Rifaximin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1

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

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


Participant Flow:   Overall Study
    Group 1     Group 2  
STARTED     19     18  
COMPLETED     16     15  
NOT COMPLETED     3     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1

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

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 Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  16     15     31  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     15     31  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  40.4  (14.3)     45.5  (16.9)     42.8  (15.6)  
Gender  
[units: participants]
     
Female     12     13     25  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
United States     16     15     31  



  Outcome Measures
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1.  Primary:   Severity of Constipation in Each Arm at Week 1 After Completion of Therapy   [ Time Frame: 1 year ]

2.  Secondary:   Change in Methane From Baseline   [ Time Frame: Baseline (Day 0) and Final Visit (Day 44) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: chuak@cshs.org


Publications:

Responsible Party: Mark Pimentel, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00945334     History of Changes
Other Study ID Numbers: 18709
Study First Received: July 23, 2009
Results First Received: February 25, 2015
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration