Rifaximin 3 Times/Day (TID) for Non-Constipation Irritabl... | NCT00724126

NCT00724126

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.	Drug: Placebo
Rifaximin	Experimental	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.	Drug: Rifaximin

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug		Rifaximin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).	The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)	The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Enoch Bortey	Bausch Health Americas, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Anniston	Alabama	36207	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21208106	Result	Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
36922331	Derived	Lacy BE, Chang L, Rao SSC, Heimanson Z, Sayuk GS. Rifaximin Treatment for Individual and Multiple Symptoms of Irritable Bowel Syndrome With Diarrhea: An Analysis Using New End Points. Clin Ther. 2023 Mar;45(3):198-209. doi: 10.1016/j.clinthera.2023.01.010. Epub 2023 Mar 14.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
FG001	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
BG001	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0001 BG0010 BG0021
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.3± 14.6 BG00145.9± 13.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000225 BG001227 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).

The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.

Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"

Posted

Number

percentage of responders

4 weeks

ID	Title	Description
OG000	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
OG001	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Units	Counts
Participants	OG000320 OG001315

Title

Denominators

Categories

Title	Measurements
	OG00032.2 OG00140.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.	0.03														Superiority or Other (legacy)

Secondary

Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)

The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.

Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."

Posted

Number

percentage of responders

4 weeks

ID	Title	Description
OG000	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
OG001	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.			7	320	94	320
EG001	Rifaximin	Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.			7	315	86	315

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Meningitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected320 at risk EG0011 affected315 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0011 affected315 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Mental status changes	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected320 at risk EG0011 affected315 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected320 at risk EG0010 affected315 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00011 affected320 at risk EG00110 affected315 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0008 affected320 at risk EG0011 affected315 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected320 at risk EG00113 affected315 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00011 affected320 at risk EG0015 affected315 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0009 affected320 at risk EG0017 affected315 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00016 affected320 at risk EG00112 affected315 at risk
Sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0004 affected320 at risk EG00110 affected315 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00030 affected320 at risk EG00127 affected315 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0008 affected320 at risk EG0017 affected315 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00026 affected320 at risk EG00120 affected315 at risk

ID	Term
D003967	Diarrhea
D015746	Abdominal Pain

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations