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Clinical Trials/CTRI/2024/12/078427
CTRI/2024/12/078427
Completed
Post Marketing Surveillance

A Prospective, Single-Arm, Multi-Centric, Open-Label, Post-Market Observational Surveillance (PMOS) Study To Evaluate The Clinico-Epidemiological Profile And Effectiveness Of A Fixed-Dose Combination (FDC) Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup For The Symptomatic Management Of Dry Cough In Patients Not Responding To Non-Opioid Based Antitussives

Abbott Healthcare Private Limited7 sites in 1 country250 target enrollmentStarted: January 14, 2025Last updated:
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Overview

Phase
Post Marketing Surveillance
Status
Completed
Enrollment
250
Locations
7
Primary Endpoint
To evaluate the clinico-epidemiological profile of patients presenting with dry cough.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is a prospective, multicenter, single-arm, open-label, Post-Market Observational Surveillance (PMOS) Study designed to evaluate the effectiveness and safety of FDC of codeine phosphate 10 mg + Triprolidine HCl 1.25 mg per 5ml oral syrup in the management of dry cough. This multicenter study will enroll 250 adult patients with dry cough, not responding to non-opioid-based antitussives. The patients will be followed up for 7 (± 2) days after enrollment into the study.

Study Design

Study Type
Pms
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of both sexes greater than18 years of age.
  • •Patients diagnosed with dry cough for at least 1 week and not responding to non-opioid-based antitussives.
  • •Patients prescribed codeine phosphate and triprolidine combination for symptomatic relief of dry cough.
  • •Dry cough associated with any etiology, as per the discretion of the treating physician and in accordance with the prescribing information.
  • •Patients willing and able to comply with the study procedures and sign the informed consent.

Exclusion Criteria

  • •Patients in whom Codeine phosphate and Triprolidine HCL are contraindicated.
  • •Patients with a known history of hypersensitivity or idiosyncratic reaction to any ingredients of the product.
  • •Patients having respiratory depression, COPD, Asthma attack.
  • •Patients having alcohol intoxication, Narrow-angle glaucoma, Urinary retention, raised intracranial tension, Head injury.
  • •Patients having peptic ulcer, Paralytic ileus, Intestinal Obstruction, Biliary or gall bladder problem.
  • •Patients having severe hypertension, severe coronary artery disease.
  • •Patients having severe hepatic or renal diseases, Mono Aminase Oxidase Inhibitor (MAOI) therapy or for 2 weeks after stopping MAOI therapy, known CYP2D6 ultra-rapid metabolizers Pregnant or breast-feeding women, Newborn or premature infants.

Outcomes

Primary Outcomes

To evaluate the clinico-epidemiological profile of patients presenting with dry cough.

Time Frame: Day 1 and 7

Secondary Outcomes

  • Effectiveness(1. To evaluate the effectiveness of codeine)

Investigators

Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Deepak Talwar

Metro Multispeciality Hospital

Study Sites (7)

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