RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

• Sponsor: University of Miami (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00364689
• Collaborator: Bausch Health Americas, Inc. (Industry)
• Enrollment: 13
• Location: 1
• Arms: 3
• Actual Duration (Months): 23
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Rifaximin; Drug: Lactulose; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
• Actual Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lactulose given with a placebo (sugar pill)	Drug: Lactulose; Other: Placebo
Experimental: lactulose given with rifaximin	Drug: Rifaximin; Drug: Lactulose
Active Comparator: rifaximin given alone	Drug: Rifaximin

Outcome Measures

Primary Outcome Measures

1. Number of Hospitalizations for Hepatic Encephalopathy (HE) [Month 7]

2. Changes in Psychometric Testing During Study Period [Month 7]

Secondary Outcome Measures

1. Number of Hospitalization Days for All Causes [Month 7]

2. Death or Survival to Liver Transplantation [Month 7]

3. Rate of Adverse Events With Rifaximin Treatment [Month 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Cirrhosis of any cause

2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment

3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.

4. Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

5. Subject is ≥18 years of age.

6. Subject is capable and willing to comply with all study procedures.

7. If the subject has a history of a portal-systemic shunt, shunt placement or revision must be >6 months from Screening for TIPS or a surgical shunt.

Exclusion Criteria:

1. Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.

2. Subject has a history of allergy or intolerance to lactulose.

3. Subject has a history of allergy or intolerance to rifampin or rifaximin.

4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening.

5. Subject is pregnant or is lactating.

6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.

7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests.

8. Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.

9. Subject's current, required medications are on prohibited concurrent medication listing.

10. Hemoglobin < 8.0 at time of screening

11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening

12. Ongoing gastrointestinal bleeding at time of screening

13. Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening

14. History of tuberculosis infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center For Liver Diseases - University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Bausch Health Americas, Inc.

Investigators

• Principal Investigator: Chakradhar Reddy, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Miami
• ClinicalTrials.gov Identifier: NCT00364689
• Other Study ID Numbers: 20060006; 20060298
• First Posted: Aug 16, 2006
• Last Update Posted: Sep 17, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by University of Miami: Encephalopathy, Hepatic; Portosystemic Encephalopathy; Encephalopathy, Hepatocerebral; Encephalopathy, Portal-Systemic; Encephalopathy, Portosystemic; Hepatic Coma; Hepatic Stupor; Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy
• Additional relevant MeSH terms: Hepatic Encephalopathy; Brain Diseases; Rifaximin; Lactulose

Study Results

Participant Flow

Pre-assignment Detail	The number of participants that were assigned to each Arm/Group is not known due to the data for this study no longer being available as the retention period has passed.

Arm/Group Title	All Participants
Arm/Group Description
Period Title: Overall Study
STARTED	13
COMPLETED	12
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone	Total
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin	Total of all reporting groups
Overall Participants	0	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Number of Hospitalizations for Hepatic Encephalopathy (HE)
Time Frame	Month 7

Outcome Measure Data

Analysis Population Description

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin
Measure Participants	0	0	0

2. Primary Outcome

Title	Changes in Psychometric Testing During Study Period
Time Frame	Month 7

Outcome Measure Data

Analysis Population Description

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin
Measure Participants	0	0	0

3. Secondary Outcome

Title	Number of Hospitalization Days for All Causes
Time Frame	Month 7

Outcome Measure Data

Analysis Population Description

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin
Measure Participants	0	0	0

4. Secondary Outcome

Title	Death or Survival to Liver Transplantation
Time Frame	Month 7

Outcome Measure Data

Analysis Population Description

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin
Measure Participants	0	0	0

5. Secondary Outcome

Title	Rate of Adverse Events With Rifaximin Treatment
Time Frame	Month 7

Outcome Measure Data

Analysis Population Description

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Arm/Group Title	Lactulose Given With a Placebo (Sugar Pill)	Lactulose Given With Rifaximin	Rifaximin Given Alone
Arm/Group Description	Lactulose Placebo	Rifaximin Lactulose	Rifaximin
Measure Participants	0	0	0

Adverse Events

Time Frame	Seven months
Adverse Event Reporting Description	Data collected for this study are no longer available because the retention period has passed and the data has been destroyed.
Arm/Group Title	All Study Participants
Arm/Group Description	All study participants enrolled in this study.
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

More Information

Certain Agreements

All Principal Investigators ARE 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.