Health Condition 1: null- Cough associated with the common cold, inhaled irritants and stable chronic bronchitis Health Condition 2: J980- Diseases of bronchus, not elsewhere classified
Conditions
Interventions
Intervention1: Guaifenesin 1200 mg and Codeine Phosphate 60 mg Extended Release Tablets: Once daily for 7 days
Control Intervention1: NIL: NIL
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. Patient with signs and symptoms of Cough associated with the common cold, inhaled irritants and stable chronic bronchitis.
Exclusion criteria
Exclusion criteria: 1. Patients<18 & >60years 2. History of hypersensitivity to the study drug or similar class of drugs. 3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 4. Pregnant or lactating women. 5. Patients with serum creatinine greater than 2.5 mg/dl. 6. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits. 7. Significant history or presence of glaucoma, cardiovascular or hematological disease. 8. Any other clinical significant illness during the 4 weeks prior to day 1 of this study. 9. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 10. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study. 11. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 12. HIV and Australian Antigen positive subjects. 13. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough, Sore throat, Throat pain, Breathlessness, PharyngitisTimepoint: Day 0, 3 and 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and TolerabilityTimepoint: Day 3 and 7 | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Outcome results
None listed