| CTRI Number |
CTRI/2014/07/004730 [Registered on: 11/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MucinexTM (Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets Safety and Tolerability Post Marketing Surveillance Study |
|
Scientific Title of Study
|
An Open Label, Multicentric Study to Evaluate the Safety and Tolerability of MucinexTM (Guaifenesin) 600 mg Extended-Release Bi-
Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2012-MUC-PMS-IN Ver 2.0 dated 12/08/2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivashankar P |
| Designation |
Medical Monitor |
| Affiliation |
Manipal AcuNova Limited |
| Address |
Manipal AcuNova Limited, Mobius Towers, SJR i-Park, Whitefield, EPIP, Bangalore,Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
918066715700 |
| Fax |
|
| Email |
shivashankar.p@ecronacunova.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Sudhir Patel |
| Designation |
Project Manager |
| Affiliation |
Manipal AcuNova Limited |
| Address |
Manipal AcuNova Limited, Mobius Towers, SJR i-Park, Whitefield, EPIP, Bangalore,Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
919740233593 |
| Fax |
|
| Email |
sudhir.patel@ecronacunova.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reckitt Benckiser LLC |
| Address |
Morris Corporate Center IV
399 Interpace Parkway
Parsippany, New Jersey 07054, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal Acunova Ltd |
Mobius Tower, SJR-i Park, EPIP, Whitefield, Bangalore - 560066 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Tripathi |
AMC Met Medical College & Sheth LG General Hospital |
Maninagar, Ahmedabad 380008
Ahmadabad
GUJARAT |
9586832257
krutesh05@yahoo.co.in |
| Dr Modi Mahavir Madhavdas |
Grant Medical Foundation – Ruby Hall clinic |
40, Sassoon Road, Pune-411001,
Maharashtra, India.
Pune
MAHARASHTRA |
919822253596
drm_modi@yahoo.co.in |
| Dr Pradeep C |
Kempegowda Institute of Medical Sciences |
Department of Medicine, K.R road, V.V Puram, Bangalore 560004
Bangalore
KARNATAKA |
9972881188
dr.cpradeep@gmail.com |
| Dr RA S Kushwaha |
King Georges Medical University |
"
Department of pulmonary medicine, King Georges Medical University chowk, Lucknow 226003
Lucknow
UTTAR PRADESH |
9415004675
drkushwaharas@gmail.com |
| Dr Ashish Nikahre |
Lata Mangeshkar Hospital |
YMCA Complex, Maharajbag Road Sitabuldi,Nagpur 440010
Nagpur
MAHARASHTRA |
918149927258
ashoonikh@gmail.com |
| Dr Prasanna Kumar |
Mandya Institute of Medical Science (Govt) |
Department of General Medicine,
Bangalore-Mysore road, Mandya- 571401
Mandya
KARNATAKA |
9886108619
amprasannakumar@yahoo.com |
| Dr M Srinivasa |
Mysore medical College & Research Institute |
Department of General Medicine, K. R. Hospital, Irwin road, Mysore 570001
Mysore
KARNATAKA |
918212520521
drsrinivasam@gmail.com |
| Dr Akash Lataru Balki |
Shree Hospital & Critical Care Center |
799, Om Nagar, Opp. Tajshree Building,
Mirchi Bazaar, Sakkardara Sq. Nagpur – 440009, Maharashtra, India.
Nagpur
MAHARASHTRA |
919890812215
akash_balki@yahoo.com |
| Dr George Dsouza |
St. John Medical College & Hospital |
Department of chest Medicine, 5th floor PFT lab, Sarjapur Road, John nagar, Bangalore-560034
Bangalore
KARNATAKA |
919449820962
dsouza.ga1975@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| AMC MET Ethics Committee |
Approved |
| Institutional Ethics Committee King George Medical University |
Approved |
| Institutional Ethics Committee Mysore Medical College |
Approved |
| Institutional Ethics Committee, Lata Mangeskar Hospital |
Approved |
| Institutional Ethics Committee, Mandya Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Poona Medical Research Foundation |
Approved |
| KIMS Institutional Ethics Committee |
Approved |
| Shree Hospitals Ethics Committee |
Approved |
| St. Johns Medical College & Hospital Institutional Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Symptoms of Cough, Thickened Mucus and Chest Congestion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guaifenesin |
1200mg twice daily for 7 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Only patients who meet all of the following criteria will be enrolled
1. Males and females (non-pregnant) patients of > 18 years of age.
2. Otherwise healthy patients suffering from cough with symptoms of thickened
mucus and chest congestion and a diagnosis of any one of the following: Acute Bronchitis, Upper respiratory tract infections such as naso-pharyngitis and Sinusitis
3. Females of child bearing potential
a. Must use efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g condom and spermicidal); IUD} or remain sexually inactive throughout the study.[Abstinence (sexually inactive) is not an acceptable form of contraception; however, abstinent female subjects will be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from that time through 30 days beyond completion of the study (Visit 2)]
b. Must have a negative urine pregnancy test (UPT) at Screening/Baseline (test must have a sensitivity of at least 25 mIU/mL for HCG).
c. Must be non-lactating.
4. Patients must demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
5. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
6. Patients must have the ability to understand and sign a written consent, which must be signed prior to study specific procedures being performed. |
|
| ExclusionCriteria |
| Details |
Patients who meet any of the following criteria will be excluded:
1. Females who are pregnant or lactating or planning to become pregnant during
the study period.
2. Patients with a history of chronic cough of 3 weeks duration.
3. Patients with any of the following conditions:
Asthma
Chronic bronchitis
Emphysema
Other chronic pulmonary conditions such as COPD or cystic fibrosis
(CF), etc.
4. Patients with known hypersensitivity to guaifenesin.
5. Patients with temperature greater than 101°F (38.3°C) at Screening/Baseline.
6. Patients with a serious and/or uncontrolled medical condition (chronic or
active liver disease, renal impairment, heart disease, diabetes, severe
respiratory disease, rheumatoid arthritis, current malignancies,
immunocompromised conditions or any other disease) that in the opinion of
the Investigator would interfere with the study or place the patient at
unacceptable risk.
7. Patients with a history or examination findings of alcohol dependence, alcohol
or drug abuse or suspected abuse within the past 2 years.
8. Patients who have participated in a study of an investigational drug within 30
days prior to the Screening/Baseline visit.
9. Patients who in the opinion of the Investigator are unable to comply fully with
the study requirements.
10. Related to persons involved directly or indirectly with the conduct of this study
(i.e., Investigator, Sub-Investigators, Study Coordinators, other study
personnel, employees of Reckitt Benckiser or Manipal AcuNova Ltd. (MAL)
and the families of each). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The number of AE(s), type of AE(s), frequency of AE(s) and proportion of patients with AE(s).
2. The severity, seriousness and the relationship of AE(s) to treatment |
7 to 9 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. End of Study Patient Questionnaire
2. End of Study Investigator Questionnaire |
7 to 9 days |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
24/01/2015 |
| 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="6"
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)?
|
Brief Summary
Modification(s)
|
This is an open label, multicentric, non-comparative, single arm prospective post marketing surveillance study to evaluate the safety and tolerability of MucinexTM (Guaifenesin, 600 mg extended-release bi-layer tablets in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to upper respiratory tract infection (URTI). Symptomatic patients coming to the outpatient department of hospitals and clinics or to general physicians who have agreed to participate in this study will be screened and enrolled into the study.
A total of 650 patients will be enrolled in the study in order to derive approximately 550 (completers) evaluable patients.
Screened: 554 patients Enrolled: 552 patients Completed: 550 patients
Study has been closed now. Last site close-out performed on 23-Feb-2016. |