| CTRI Number |
CTRI/2014/10/005150 [Registered on: 28/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A RANDOMISED CONTROLLED TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED COMPARATIVE OPEN LABEL TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HEMALATHA T |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,KOZHIKODE |
| Address |
Dr.HEMALATHA T,
JUNIOR RESIDENT,
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE-673008.
Kozhikode
KERALA
673008
India |
| Phone |
9746615918 |
| Fax |
|
| Email |
hemalini11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNARAYANAN PV |
| Designation |
PROFESSOR & HOD |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,KOZHIKODE |
| Address |
Dr.NARAYANAN.P.V,
PROFESSOR & HOD,
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE-673008.
Kozhikode
KERALA
673008
India |
| Phone |
9946316580 |
| Fax |
|
| Email |
narayananpv55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HEMALATHA T |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,KOZHIKODE |
| Address |
Dr.HEMALATHA T,
JUNIOR RESIDENT,
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE-673008.
Kozhikode
KERALA
673008
India |
| Phone |
9746615918 |
| Fax |
|
| Email |
hemalini11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.HEMALATHA T,
JUNIOR RESIDENT,
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGEKOZHIKODE |
| Address |
Dr.HEMALATHA T,
JUNIOR RESIDENT,
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE-673008 |
| Type of Sponsor |
Government medical college |
|
|
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 HEMALATHA T |
GOVERNMENT MEDICAL COLLEGE,KOZHIKODE |
DEPARTMENT OF PHARMACOLOGY,
GOVERNMENT MEDICAL COLLEGE,
KOZHIKODE-673008
Kozhikode
KERALA |
9746615918
hemalini11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MEDICAL COLLEGE,CALICUT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G839||Paralytic syndrome, unspecified, SPASTICITY IN ACQUIRED SPINAL CORD INJURIES, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACLOFEN 5mg TDS ORALLY AFTER FOOD FOR 3 MONTHS |
BACLOFEN AS THE INTERVENTION AGENT FOR THE MANAGEMENT OF SPASTICITY FOR THREE MONTHS.PATIENT MAY CONTINUE BACLOFEN THEREAFTER BASED ON THE CLINICAL CONDITION BUT MY FOLLOW UP PERIOD IS 3 MONTHS |
| Comparator Agent |
DIAZEPAM 5 Mg TDS FOR 3 MONTHS ORALLY AFTER FOOD. |
DIAZEPAM AS A COMPARATOR AGENT FOR THE MANAGEMENT OF SPASTICITY.THE PATIENT MAY CONTINUE DIAZEPAM BEYOND 3 MONTHS BASED ON THE CLINICAL CONDITION BUT MY STUDY PERIOD IS FOR 3 MONTHS FOLLOW UP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent
2.Age 18 years and above
3.Patients after two months of spinal cord injury with established spasticity and not in spinal shock
4.Spasticity due to spinal cord injury of all grades
5.Spasticity interfering with sleep and functional capacity
|
|
| ExclusionCriteria |
| Details |
1.Significant history of Hypersensitivity to the study drugs
2.Respiratory disorders like COPD, Sleep apnoea
3.Chronic liver disease
4.Renal disease
5.With psychiatric illness of any kind
6.Broken skin and any infections trigerring spasticity
7.Patients receiving drugs interfering significantly with the study drugs
8.Patients planned for surgical intervention
9.Glaucoma
10.Myasthenia gravis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN SPASTICITY AS OBTAINED BY IMPROVEMENT IN FUNCTIONAL INDEPENDENCE MEASURE SCORE;MONITORING ADVERSE DRUG REACTION DURING STUDY PERIOD |
DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE ADVERSE DRUG PROFILE OF BACLOFEN WITH THAT OF DIAZEPAM |
DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/02/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised controlled comparative open label trial on the safety and efficacy of baclofen 5mg tds with that of diazepam 5mg tds in spasticity due to spinal cord injuries conducted at government medical college ,kozhikode. The primary outcome measure of the study is improvement in spasticity as assessed by functional independence measure ;the adverse drug reaction is also monitored during the study period |