| CTRI Number |
CTRI/2010/091/003045 [Registered on: 31/01/2011] |
| Last Modified On: |
24/03/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to compare Rifaximin with Lactulose in improving psychometric test performance in patients with cirrhosis and minimal hepatic encephalopathy. |
Scientific Title of Study
Modification(s)
|
To compare the efficacy of rifaximin and lactulose in improving minimal hepatic encephalopathy in patients with cirrhosis: a single blind, randomised, active-comparator, non-inferiority trial
|
| Trial Acronym |
(ALARM: Active Comparator Trial of Lactulose & Rifaximin In MHE) |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sandeep S Sidhu |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
01614687340 |
| Fax |
01612302620 |
| Email |
dmcgastro@in.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sandeep S Sidhu |
| Designation |
|
| Affiliation |
Professor |
| Address |
Dept of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
01614687340 |
| Fax |
01612302620 |
| Email |
dmcgastro@in.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sandeep S Sidhu |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
01614687340 |
| Fax |
01612302620 |
| Email |
dmcgastro@in.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Gastroenterology
D.M.C. and Hospital,
Tagore Nagar, Ludhiana. 141001
Tel: 0161-4687340, 4687315, Fax: 0161-2302620 |
|
Primary Sponsor
Modification(s)
|
| Name |
Department of Gastroenterology |
| Address |
D.M.C. and Hospital, Tagore Nagar, Ludhiana. 141001Tel: 0161-4687340, 4687315, Fax: 0161-2302620 |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep S Sidhu |
Dept of Gastroenterology |
DMC and Hospital,-141001
Ludhiana
PUNJAB |
0161-4687340
01612302620
dmcgastro@in.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Cirrhosis with minimal hepatic encephalopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lactulose syrup |
30-90 ml per day in divided doses, per oral |
| Intervention |
Rifaximin tablets |
400 mg thrice a day, per oral |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Age 18-65 years
-Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and/or liver histology data.
-Minimal hepatic encephalopathy diagnosed by abnormalities in psychometric tests |
|
| ExclusionCriteria |
| Details |
-Known allergy to rifaximin/rifabutin or lactulose.
-Current or recent (< 6 weeks) use of alcohol
-Use of antibiotics within last 6 weeks
-Use of lactulose, lactitol, L-ornithine L-aspartate, zinc, metronidazole, neomycin, or rifaximin within the last 6 weeks
-Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks
-Infection or gastrointestinal haemorrhage within the last 6 weeks
-Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance
-Hepatocellular carcinoma
-History of porto-systemic shunt surgery or transjugular intrahepatic portosystemic shunt (TIPS)
-Pregnancy and breastfeeding
-Neurological or psychiatric problems which may influence quality of life measurement.
-Poor vision or motor defects which interfere with the performance of psychometric tests.
-Current or recent (< 6 months) history of overt hepatic encephalopathy. This would be excluded by:
o Detailed history taking from patient, friends/relatives
o Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
o Focus on lack of awareness, alertness, anxiety or euphoria (To rule out grade 1 hepatic encephalopathy)
o Mini-mental status examination score > 25
-Women of child-bearing potential who is not using two effective methods of contraception.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in psychometric test performance. |
3 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in health related quality of life |
3 months |
| Tolerability of rifaximin and lactulose |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
01/02/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/02/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, single blind, active comparator, non-inferiority single centre trial. It will compare the efficacy of rifaximin with lactulose in improving psychometric test performance in patients with cirrhosis with minimal hepatic encephalopathy, when given for a period of 3 months. The primary outcome measure will be improvement in psychometric test performance, and the secondary outcome measures would be improvement in health related quality of life, and tolerability of rifaximin and lactulose. |