| CTRI Number |
CTRI/2022/03/041394 [Registered on: 25/03/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| 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 clinical study to assess the efficacy and safety of combination of Noscapine plus Chlorpheniramine Syrup in patients for the treatment of cough with running nose. |
|
Scientific Title of Study
|
“A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Noscapine and Chlorpheniramine Maleate Oral Syrup in Patients for the Treatment of Dry, Irritating Cough Associated with Running Nose.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/2022/02, Version No.: 00 and Dated Jan 28, 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar, Near Ramalayam Temple,
Kukatpally, Hyderabad-500072,
Telangana.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddalingaiah N |
| Designation |
Deputy General Manager - Medico Marketing |
| Affiliation |
Biological E Limited |
| Address |
Biological E Limited,
Plot No.623-H, Jubilee Hills, Hyderabad-500033.
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216234 |
| Fax |
|
| Email |
Siddalingaiah.Ningaiah@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddalingaiah N |
| Designation |
Deputy General Manager - Medico Marketing |
| Affiliation |
Biological E Limited |
| Address |
Biological E Limited,
Plot No.623-H, Jubilee Hills, Hyderabad-500033.
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216234 |
| Fax |
|
| Email |
Siddalingaiah.Ningaiah@biologicale.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Biological E Limited |
| Address |
18/1 & 3, Azamabad,
Hyderabad-500020,
Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amitava Pal |
College of Medicine and Sagore Dutta Hospital |
Department of Chest Medicine, 578, B.T Road, Kamarhati, Kolkata-700058.
Kolkata
WEST BENGAL |
8981563716
amitava85@gmail.com |
| Dr Swapnav Borthakur |
Down Town Hospital |
Research Room, Dispur, G.S. Road, Guwahati-781006.
Kamrup
ASSAM |
9864038704
swapnav.borthakur@gmail.com |
| Dr MG Krishna Murthy |
Gandhi Medical College and Hospital |
Department of Respiratory Medicine, 8th Floor, In Patient Block, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9849135461
imkrishna@rediffmail.com |
| Dr Raghumanda Sunil Kumar |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Pulmonology, Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
9849126543
drsunilkumarrims@gmail.com |
| Dr Sanjay Verma |
GSVM Medical College |
Department of Pulmonology,
Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
9415075458
drskverma78@rediffmail.com |
| Dr Neeraj Gupta |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of Pulmonary Medicine, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9829101942
drneerajajmer@yahoo.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Room No. 109, Basement, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Raja Bhattacharya |
Medical College and Hospital, Kolkata |
Department of Medicine, MCH
Building, 4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
9477305539
rbrbhattacharya@gmail.com |
| Dr Vijaykumar Bhagwan Barge |
Rajarshee Chhatrapati Shahu Maharaj GMC and Chhatrapati Pramila Raje General Hospital |
Department of Medicine, Dasara
Chowk, Town Hall, Bhausingji Road, Kolhapur-416002.
Kolhapur
MAHARASHTRA |
8080328480
rcsmgmc.research@gmail.com |
| Dr Vivek Eknath Redkar |
Redkar Hospital and Research Centre |
Research Room, Mumbai-Goa Highway, Oxelbag, Dhargal, Tal-Pernem, Goa-403513.
North Goa
GOA |
9422633506
redkar.research@gmail.com |
| Dr Harendra Yadav |
Vidhya Hospitals & Trauma Centre |
Department of Pulmonology, Harikansgadi, Mohanlalganj, Raebareli Road, Lucknow-226301.
Lucknow
UTTAR PRADESH |
8953323348
vidhyahospitals980@gmail.com |
| Dr Neeraj Gupta |
W Pratiksha Hospital |
Research Room, Golf Course Ext. Road, Sushant Lok II,
Sector 56, Gurugram-122011.
Gurgaon
HARYANA |
7834846143
neeraj.gupta@w-hospital.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Submittted/Under Review |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee for Human Research Medical College |
Approved |
| Institutional Ethics Committee, College of Medicine & Sagore Dutta Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Gandhi Medical College / Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH) |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| North East Healthcare Private Limited, W Pratiksha Hospital |
Approved |
| Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2) |
Approved |
| Redkar Hospital Institutional Ethics Committee (RHIEC) |
Approved |
| Vidhya Hospital and Trauma Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Dextromethorphan 10 mg plus Chlorpheniramine Maleate 4 mg Oral Syrup |
Patients will be advised to take 5 mL of oral syrup 4 times daily for 7 days. |
| Intervention |
FDC of Noscapine 15 mg plus Chlorpheniramine Maleate 4 mg Oral Syrup |
Patients will be advised to take 5 mL of oral syrup 4 times daily for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 12 to 65 years (both inclusive).
2. Patients with a diagnosis of dry, irritating cough associated with running nose at screening visit.
3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
4. Patient with ability to understand and provide written informed consent / assent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements throughout the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Patients who had initiation of allergen immunotherapy within previous 6 months.
3. Patients with history of Rhinitis medicamentosa or substantial structural nasal obstruction.
4. Patients with the presence of nasal polyps or any clinically important nasal anomaly.
5. Patients with the history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
6. Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
7. Patients with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
8. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
9. Female patients who are not ready to use acceptable contraceptive methods during the study.
10. Patients with known case of HIV, Hepatitis B & C.
11. Patients with medical history of oncological conditions.
12. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patient’s participation in the study.
13. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
14. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
15. Patients with suspected inability or unwillingness to comply with the study procedures.
16. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in cough severity score (CSS) from baseline to end of the study visit. |
At Visit 1 / Day 1 and Visit 3 / Day 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Runny nose severity assessment from baseline to end of the study visit. |
At Visit 1 / Day 1 and Visit 3 / Day 7. |
| Change in Leicester Cough Questionnaire (LCQ) from baseline to end of the study visit. |
At Visit 1 / Day 1 and Visit 3 / Day 7. |
| Mean change in cough severity score (CSS) from baseline to day 3. |
At Visit 1 / Day 1 and Visit 2 / Day 3. |
| Percentage change in cough severity score (CSS) from baseline to day 3 and end of the study visit. |
At Visit 1 / Day 1, Visit 2 / Day 3 and Visit 3 / Day 7. |
Adverse events or Serious adverse events reported during the study.
|
At Visit 2 / Day 3 and Visit 3 / Day 7. |
| Changes in clinical laboratory parameters from baseline to end of the study visit. |
At Visit 1 / Day 1 and Visit 3 / Day 7. |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "198"
Final Enrollment numbers achieved (India)="198" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
10/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
|
Brief Summary
|
This
trial is a phase III, prospective, randomized, double blind, active-controlled,
comparative, parallel group, multicentric clinical study to evaluate the efficacy,
safety and tolerability of FDC of Noscapine and Chlorpheniramine Maleate Oral
Syrup in patients for the treatment of dry, irritating cough associated with running
nose.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent / Assent Form on the day of screening / baseline visit (Visit
1). During this screening period, patients who are willing to give consent /
assent will be evaluated for all the eligibility criteria. Eligible patients
with a diagnosis of dry, irritating cough associated
with running nose at screening visit will be considered for the study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on day 3 and day 7(±1) (Final Visit) of
treatment to assess efficacy, safety and tolerability.
Patients
will be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDC
of Noscapine 15 mg + Chlorpheniramine Maleate 4 mg Oral Syrup or FDC of
Dextromethorphan 10 mg + Chlorpheniramine Maleate 4 mg Oral Syrup. |