| CTRI Number |
CTRI/2018/04/013139 [Registered on: 10/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study of baclofen in subjects with spasticity |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN-LABEL, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE,
MULTIPLE DOSE, CROSSOVER STUDY TO ASSESS BIOAVAILABILITY AND STEADY STATE
PHARMACOKINETICS OF BACLOFEN 30 MG ER CAPSULES (GRS) OF SUN
PHARMACEUTICAL INDUSTRIES LIMITED, INDIA GIVEN ONCE DAILY, UNDER FED
(NORMAL MEAL) CONDITIONS, FOR 8 CONSECUTIVE DAYS.
Vs
BACLOFEN 10 MG IR TABLETS OF IVAX PHARMACEUTICALS, INC., MIAMI, FL 33137,
GIVEN THREE TIMES A DAY AT 8 HOUR INTERVAL, WITH THE INITIAL DOSE
ADMINISTERED UNDER FASTING CONDITION, FOR 8 CONSECUTIVE DAYS, IN 24 SPASTIC
SUBJECTS RECEIVING STABLE DAILY DOSES OF BACLOFEN. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLR_09_08 Version 02 dated 8 Jun 2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
Sun Pharma Advanced Research Company Limited,
17/B, Mahal industrial estate, mahakali caves road, Andheri- 400093
Mumbai
India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
Sun Pharma Advanced Research Company Limited,
17/B, Mahal industrial estate, mahakali caves road, Andheri- 400093
Mumbai
India
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal industrial estate, mahakali caves road, Andheri- 400093
Mumbai
India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advance Research company Limited
17-B, Mahal Industrial Estate, Mahakali Caves road, Andheri (East), Mumbai 400093. |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceuticals Industries Ltd |
| Address |
Acme Plaza, Andheri - Kurla Rd, Andheri (E),
Mumbai - 400 059
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mallika Khanna |
Aman Nursing home |
Aman Nursing Home, 1st floor,
Krishna Complex, Hari Nagar Cross Road,
Gotri Road,
Vadodara – 390021.
Vadodara
GUJARAT |
919324382046
mallikaamankhanna@gmail.com |
| Dr Vijay Sheth |
Brain & Spine Hospital |
Neuro Care Clinic,Kharivav Road,
Dandia Bazar,
Baroda – 390001
Vadodara
GUJARAT |
919979530073
ndudhatra.icubecr@gmail.com |
| Dr Bashir A Ahmadi |
Dr. Bashir A. Ahmadis Clinic |
M-4, Mahakant,Mezzanine floor,
Ashram Road,Opp V. S. Hospital,
Ellisbridge,
Ahmedabad – 380006
Ahmadabad
GUJARAT |
9979530073
ndudhatra.icubecr@gmail.com |
| Dr Bhavin Upadhyaya |
Neuro Care Clinic |
Neuro Care Clinic,Kharivav Road,
Dandia Bazar,
Baroda – 390001
Baroda – 1
Vadodara
GUJARAT |
91-265-2434644
bhavin.upadhyay@accutestindia.com |
| Dr Anand Diwan |
Shatabdi Superspeciality Hospital |
Suyojit City CentreMumbai Naka,Nashik – 422005.
Nashik
MAHARASHTRA |
919960005088
Dr_andu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| IEC |
Approved |
| IEC |
Approved |
| IEC |
Approved |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, Subjects with spasticity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACLOFEN ER CAPSULES (GRS) |
30 MG once daily for 8 days |
| Comparator Agent |
BACLOFEN IR TABLETS |
10 MG Thrice daily for 8 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Availability of subject for the entire study period and willingness to adhere to protocol
requirements
- Subjects with history of spasticity for 1 year or more
- Spastic subjects receiving stable daily doses of Baclofen 30mg for at least 1-month prior to
start of study.
- Subjects at least 18-years of age or older, subjects having weight at least 50Kg and the
subject’s body mass index (BMI) must be within 18.5 to 25.0 (Kg/m2) (inclusive). |
|
| ExclusionCriteria |
| Details |
- Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or
any related compounds etc.
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,
immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease that interferes
with study procedures.
- Subject having history of seizure.
- Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
past one year |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC and Tmax |
PK analysis:
pre-dose, and dosing on Day 6 (Dose 6), Day 7 (Dose 7) and Day 8 (Dose 8). On Day 8, the post-dose blood samples were collected at
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 20.0, and 24.0 hr . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vital signs (seated BP and pulse rate) and safety |
after check-in, pre-dose and at 2.0,
4.0, 8.0, and 12.0 hours (± 30 minutes) post dose on Day 8 and at checkout
(except for evening dose 4.0 and 8.0 hours (±30minutes) post dose for which
blood pressure, pulse rate will be recorded in the supine position). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2009 |
| 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="0"
Months="7"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective to monitor safety and assess bioavailability and steady-state pharmacokinetics of once daily Baclofen 30 mg Extended-Release Capsules (GRS) administered in morning or in evening in 24 spastic subjects receiving stable daily doses of Baclofen was achieved.The pharmacokinetic parameters and Baclofen plasma concentration-time profiles were similar for the test and reference formulations. In addition, there was no significant difference in the pharmacokinetic parameters with AM or PM dosing indicating that time of dose did not influence pharmacokinetics of Baclofen GRS. |