| CTRI Number |
CTRI/2011/07/001877 [Registered on: 12/07/2011] Trial Registered Retrospectively |
| Last Modified On: |
12/07/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative, multi-center, open label, randomized, parallel group Efficacy and Safety Study of Benzonatate 100 mg soft gel capsule for the symptomatic treatment of acute non-productive cough |
|
Scientific Title of Study
|
A comparative, multi-center, open label, randomized, parallel group Efficacy and Safety Study of Benzonatate 100 mg soft gel capsule for the symptomatic treatment of acute non-productive cough |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 06/2009 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfDr Tapan Kumar Pal |
| Designation |
Director |
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
03324146967 |
| Fax |
03324146266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Sabhait |
| Designation |
|
| Affiliation |
|
| Address |
Bioocn Ltd., 20th KM, Electronic City, Hosur Road, Bangalore- 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
08028523423 |
| Fax |
08028523423 |
| Email |
vanita.sabhahit@biocon.com |
|
|
Source of Monetary or Material Support
|
| Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
|
|
Primary Sponsor
|
| Name |
Biocon Ltd |
| Address |
20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bioequivalence Study Centre |
Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
| TAAB Biostudy Services |
27, Central Road, Jadavpur, Kolkata-700032 |
|
|
Countries of Recruitment
|
|
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Arunava Biswas |
Calcutta National Medical College |
Calcutta National Medical College,,32 Gorachand Road-700014
|
09433110797
drabiswas@gmail.com |
| Dr. T. K. Chattaraj |
Dafodil Nursing Home Pvt. Ltd. |
Dafodil Nursing Home Pvt. Ltd.,276 Canal Street-700048
Kolkata
WEST BENGAL |
9831070050
asmi_1234@rediffmail.com |
| Dr. R. G. Bhagat |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik,,Dashaporwad Society , Gajarawala Flats Lane, B/h. Paldi Bus Stand, Paldi ,-380007
Ahmadabad
GUJARAT |
07926574746
rajpurvi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. R. G. Bhagat) |
Approved |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. T. K. Chattaraj)) |
Approved |
| Institutional ethics committee (Dr. Arunava Biswas) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from acute non-productive cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Benzonatate 100 mg soft gel capsule |
one soft gel capsule taken (swallow) thrice daily |
| Comparator Agent |
Dextromethorphan 10mg |
every 4 hours |
| Comparator Agent |
Dextromethorphan 30mg |
Every 6 Hours |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients willing to provide written informed consent to participate in the study
ii) Male and Female patient in the age range of 10-65 years.
iii) Patients with acute (defined as less than 3 week duration) non-productive cough presenting in out patient setting.
iv) Patients with a baseline daytime cough symptom score of at least 2.
v) Patients must be literate so that no one of them should chew the soft gel capsule inside the mouth which may be dangerous.
|
|
| ExclusionCriteria |
| Details |
i) Female patients of child bearing potential or male study patient who has a partner of childbearing potential, who refuses to use a medically acceptable form of contraception throughout the study.
ii) Female patient who is pregnant or lactating.
iii) Patients with chronic cough (cough 3 weeks duration)
iv) Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis), asthma or having incidences of self-reported wheeze, chronic obstructive pulmonary disease with history any concurrent airway disease (eg. tonsillitis, sinusitis, deviated nasal septum, polyps etc.)
v) Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies;
vi) Patients with history of allergy to local anesthetics or topical anesthetics of the para-amino- benzoic acid class (e.g. procaine; tetracaine; benzocaine) or other ester-type local anesthetics.
vii) Patients currently on any treatments that may influence cough.
viii) Patient has hepatic insufficiency or at screening presents with AST or ALT 2 times the upper limit of normal (ULN) or bilirubin 1.5 times the ULN.
ix) Patients with renal impairment or at screening presents with serum creatine 1.4 mg/dL or Blood Urea 40 mg/dL.
x) Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator;
xi) Use of any investigational drug or participation of any clinical trial within 30 days prior to this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the daytime cough symptom scores at end of 5 days (120 hrs) of first examination as compared to the baseline. |
5 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in day and night time cough scores on days 5-7 as compared to baseline |
5-7 Days |
| Change in Night time score from the baseline at end of 5 days (120 hrs) of first examination as compared to the baseline |
5 Days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/01/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to compare efficacy and safety of benzonatate 100 mg soft gel capsule for the symptomatic treatment of acute non-productive cough. The Study agent is benzonatate100 mg soft gel capsule taken (swallow) thrice every day and the comparator agent is dextromethorphan 10mg doses every 4 hours or 30 mg every 6 hours (as prescribed by the physician). The study will be conducted on 200 patients in 3 different centers in India for 3 months. |