Rifaximin 3 Times/Day (TID) for Non-Constipation Irritabl... | NCT00731679

Status Module

Oversight 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

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

Facility	Status	City	State	ZIP	Country	Contacts
		Hueytown	Alabama	35023	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.

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

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 BG0011 BG0022
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.5± 14.6 BG00146.2± 15.0 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000222 BG001235 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0012 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]"

The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.

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	OG000314 OG001309

Title

Denominators

Categories

Title	Measurements
	OG00031.2 OG00140.8

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.	0.01														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]."

The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.

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

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.			8	314	101	314
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.			3	309	103	309

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 affected314 at risk EG0011 affected309 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected314 at risk EG0011 affected309 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Amnesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected314 at risk EG0011 affected309 at risk
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk
Labile hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0010 affected309 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected314 at risk EG0017 affected309 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00023 affected314 at risk EG00119 affected309 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00015 affected314 at risk EG00114 affected309 at risk
Flatulence	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00011 affected314 at risk EG0016 affected309 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00013 affected314 at risk EG00122 affected309 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0008 affected314 at risk EG00111 affected309 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0008 affected314 at risk EG0016 affected309 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00018 affected314 at risk EG0017 affected309 at risk
Sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00012 affected314 at risk EG0017 affected309 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0009 affected314 at risk EG0018 affected309 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0006 affected314 at risk EG0017 affected309 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected314 at risk EG0013 affected309 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00016 affected314 at risk EG00118 affected309 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 affected314 at risk EG0019 affected309 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected314 at risk EG0017 affected309 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00012 affected314 at risk EG0018 affected309 at risk

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

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