A post marketing surveillance study to monitor the safety and efficacy of Codeine phosphate and Chlorpheniramine maleate for management of symptoms of dry cough in adult patients.
- Conditions
- Health Condition 1: J988- Other specified respiratory disorders
- Registration Number
- CTRI/2021/10/037217
- Lead Sponsor
- ABORATE Pharmaceuticals India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized
or practicing a reliable method of birth control during the duration of study)
Subjects with age ranging from 18 to 65 years (both inclusive).
2. Subjects having dry cough (less than 7 days) of any origin and may be with related
symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if
present) (absence of bronchial mucus/phlegm production).
3. Not under any antibacterial or antiviral treatment before recruitment.
4. Subjects ready to abstain from using any drug (which will affect the study
outcome) other than Investigational Product for the treatment of the study condition
during the study period (except in cases when patientââ?¬•s condition worsens as per
study physician. In this case, Study physician will decide to prescribe antibiotic, if
required).
5. Ready to abstain from the administration of any herbal or ayurvedic treatment or
gargles directed to ease coughing or throat parameters.
6. Willing to provide written informed consent
7. Willing and able to understand and comply with all study requirements
1. Subjects with known allergy or hypersensitivity to Codeine Phosphate or
Chlorpheniramine Maleate or any of its components.
2. Subjects who had taken any medicated confectionary, throat pastille, spray or any
product with demulcent properties, any cough medicines or drugs containing
antihistamines within last 24 hours prior to screening.
3. Subjects taking medications with known cough promoting side effects (e.g.,
angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that
in the opinion of the investigator are causing symptoms of cough.
4. Subjects with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic
rhinitis, as well as heart disease.
5. Severe cough requiring hospitalization
6. Subjects who had used any local anesthetic within the past 24 hours.
7. Subjects who have used a longer acting or slow release analgesic during the
previous 24 hours.
8. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse,
or serious neurological or psychological disease
9. Any other condition, which in the opinion of the clinician/investigator, could
interfere significantly with the treatment and assessment process
10. Use of any investigational therapy within 30 days prior to randomization
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events, Serious Adverse Events, Unexpected Adverse Events, Adverse Drug Reactions and Treatment Emergent Adverse Events. <br/ ><br>Timepoint: 7 Days
- Secondary Outcome Measures
Name Time Method Change in score of throat pain and throat irritationTimepoint: Day 7;Change in the cough severity( daily) and frequency (daily) score assessed during <br/ ><br>follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is <br/ ><br>earlier) compared to the baseline.Timepoint: Day 3 and Day 7;Number of awakenings in the night due to cough (24 hours) assessed during follow-up visitTimepoint: Day 7;Time taken for complete cough relief (days) assessed during follow-up visitTimepoint: Day 7