| CTRI Number |
CTRI/2013/04/003588 [Registered on: 26/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy and safety of Baclofen and Chlordiazepoxide in Alcohol Withdrawal Syndrome. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF BACLOFEN AND CHLORDIAZEPOXIDE IN ALCOHOL WITHDRAWAL SYNDROME
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VIKRAM REDDY K |
| Designation |
POST-GRADUATE/RESIDENT |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT OF PHARMACOLOGY,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,B.S.K 2ND STAGE, BANGALORE – 560 070
Bangalore
KARNATAKA
560070
India |
| Phone |
8951234632 |
| Fax |
|
| Email |
vikramred777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GIRISH K |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT OF PHARMACOLOGY,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,B.S.K 2ND STAGE, BANGALORE – 560 070
Bangalore
KARNATAKA
560070
India |
| Phone |
9980911060 |
| Fax |
|
| Email |
drgirish_k@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GIRISH K |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT OF PHARMACOLOGY,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,B.S.K 2ND STAGE, BANGALORE – 560 070
Bangalore
KARNATAKA
560070
India |
| Phone |
9980911060 |
| Fax |
|
| Email |
drgirish_k@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr VIKRAM REDDY K |
| Address |
#332,C.T.BED, T.R.NAGAR, B.S.K 2ND STAGE, BANGALORE – 560028 |
| Type of Sponsor |
Other [Resident ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VIKRAM REDDYK |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE (KIMS) HOSPITAL, BANGALORE |
DEPT OF PSYCHIATRY,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE (KIMS) HOSPITAL, BANGALORE
Bangalore
KARNATAKA |
8951234632
vikramred777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Alcohol Withdrawal Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baclofen 10 mg |
Baclofen 10 mg in following schedule TID up to 3 days, BD up to 3 days and OD up to 3 days |
| Comparator Agent |
Chlordiazepoxide 25mg |
Chlordiazepoxide 25mg in following schedule TID up to 3 days, BD up to 3 days and OD up to 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Subjects with alcohol dependence according to DSM-IV (TR) criteria.
b. Last alcohol intake within 24 hour preceding the initiation of study.
c. Willingness to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
a. Patients with known psychiatric disorders.
b. Patients with known renal and cardiovascular diseases.
c. Patients with known allergy to study medications.
d. Patients with multi-drug abuse.
e. Patients with any other substance dependence except nicotine.
f. Patients with delirium tremens.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
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Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of baclofen with chlordiazepoxide in AWS as assessed by Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar score).
Primary Outcome: lowering in CIWA-Ar severity scores. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Global Impression(CGI) Scales.
1.Decrease in CGI-severity scale.
2.Increase in CGI-improvement scale and
3.Change in CGI-efficacy index score according to therapeutic and side effects. |
10 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a open label, randomized, controlled, two arm clinical trial to compare the efficacy and tolerability of baclofen and chlordiazepoxide in alcohol withdrawal syndrome, Baclofen 10 mg will be administered in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days and Chlordiazepoxide at a dose of 25mg in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days. The efficacy of study drugs will be assessed everyday using CIWA-Ar scale and adverse effects will be recorded. Lorazepam/Haloperidol (IM) will be used as rescue medication.
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