A Study to compare the Effectiveness and Safety of Gefapixant in Adult Patients with Chronic Cough
Scientific Title of Study
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Patients with Chronic Cough
Trial Acronym
GeCCough
Secondary IDs if Any
Secondary ID
Identifier
ICR/24/001 Version No. 2.0 Dated 28/AUG/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited.
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243245598
Fax
02243244324
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited.
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244324
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2 – Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited.
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244324
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited (SPLL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited SPLL
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
SPARC, Tandalja, Vadodara - 390 012, Gujarat, India.
Ethics Committee Atmaram Child Care and Critical Care
Submittted/Under Review
Ethics committee G.S.V.M medical College, Kanpur
Approved
Ethics Committee of Pulse Multispecialty Hospital
Submittted/Under Review
Ethics Committee Shanti Hospital
Approved
Ford Hospital Ethics Committee
Submittted/Under Review
Health1 super speciality hospital Ethics Committee
Submittted/Under Review
IEC, Maharaja Agrasen Hospital
Approved
IEC, Vincare Hospital
Approved
Institutional Ethics Committee Aatman Hospital
Submittted/Under Review
Institutional Ethics Committee Jawahar Lal Nehru Medical College
Submittted/Under Review
Institutional Ethics Committee S.N Medical College
Submittted/Under Review
Institutional Ethics Committee Sparsh Hospitals and Critical Care Private Limited
Submittted/Under Review
Institutional Ethics Committee, MLN Medical College
Submittted/Under Review
Institutional Ethics Committee. NRS Medical College and Hospital
Submittted/Under Review
KIDS Ethics Committee
Approved
Ojas Multispeciali ty Hospital Ethics Committee
Approved
Riddhi Medical Nursing Home IEC
Approved
Shree Siddhivinayak Hospital Ethic Committee
Approved
Supe Hospital Ethics Committee
Submittted/Under Review
Suraksha Ethics Committee
Approved
Visakha Institute of Medical Sciences
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: R05||Cough,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Gefapixant 45 mg Tablets
1 tablet of Gefapixant Tablets 45 mg twice daily for 12 weeks
Comparator Agent
Placebo tablets of Gefapixant
1 tablet of Placebo twice daily for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either sex, aged 18 to 65 years and ready to give written informed consent to participate in the study.
2. Willing and able to comply with all aspects of the protocol, including agreeing not to smoke during the study and demonstrating an ability to follow study procedures to the satisfaction of the Investigator/qualified designee prior to randomization.
3. Patient having a Computerised Tomography (CT) scan of thorax (within 1 year of Screening and after the onset of chronic cough) not demonstrating any clinically significant abnormality contributing to the chronic cough or any other clinically significant respiratory disease, in the opinion of the Investigator
4. Patient with chronic cough (defined as duration of more than 8 weeks after onset of cough symptoms) for less than 12 months prior to the screening visit (i.e., less than 14 months after onset of cough symptoms), based on documented medical history of patients.
5. Patient with diagnosis of refractory chronic cough or unexplained chronic cough as per the current American College of Chest Physicians (ACCP) guidelines
6. Women of childbearing potential (WOCP) must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till 2 weeks after the last dose of the study medication
ExclusionCriteria
Details
1. Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes or history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
2. Patient having a force expiratory volume (FEV1) /forced vital capacity (FVC) ratio less than 60%.
3. Patient with a history of upper or lower respiratory tract infection or recent clinically significant change observed in pulmonary status within 4 weeks of screening.
4. Patient with history of chronic bronchitis.
5. Patient who has previously received Gefapixant or other P2X purinocepter 3 (P2X3) antagonists.
6. Patient is currently enrolled in an investigational drug or device study.
7. Patient with history of participation in another clinical trial in the past 6 months prior to screening or planning to participate during the study
8. Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements
9. Patient with any surgery or medical procedure planned during the screening, treatment or follow-up periods
10. Pregnant, lactating women or women who intend to conceive or women of childbearing age who are not willing to use an acceptable method of birth control during the study period
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant
relative to placebo assessed at Week 12 (2-week recall period)
Change from Baseline in the Leicester Cough Questionnaire (LCQ) total score with Gefapixant
relative to placebo assessed at Week 12 (2-week recall period)
Secondary Outcome
Outcome
TimePoints
Change from Baseline in the LCQ total score
Weeks 4 and 8 (2-week recall period)
Change from Baseline in the Cough Severity VAS score
Weeks 4, 8, and 12
Patient Global Impression of Change scale response
Weeks 4, 8, and 12
Incidence of TEAEs and SAEs
Throughout the study period
Target Sample Size
Total Sample Size="438" Sample Size from India="438" 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)
05/07/2025
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="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, parallel-group, prospective, multicenter, double-blind, two-arm, placebo-controlled, Phase 3 comparative study. The study will be conducted at approximately 15-20 centers in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment.
After confirming the eligibility, patients will be randomized by allotting the randomization number. Patients will be either randomized to Test arm (Gefapixant 45 mg Tablets) OR to Comparator arm (Matching Placebo tablets for Gefapixant).