Health Condition 1: J00- Acute nasopharyngitis [common cold] Health Condition 2: R05- Cough
Conditions
Interventions
Intervention1: FDC of Dextromethorphan 10 mg + Phenylephrine 5 mg per 5 mL Syrup: Patients will be advised to take 10 mL of FDC of Dextromethorphan 10 mg + Phenylephrine 5 mg per 5 mL Syrup orally thr
Sponsors
Zydus Healthcare Limited
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18 to 65 years (both inclusive) at the time of signing consent. 2. Patients diagnosed with acute cough of less than 7 days duration at the time of consent, associated with common cold. 3. Patients with cough severity score of at least 40 mm on 100 mm visual analogue scale (VAS) at screening or baseline visit. 4. Women of childbearing potential 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 end of the study visit. 5. Patient with ability to understand and provide written, signed and dated informed consent form which must have been obtained prior to screening. 6. Patients are willing and able to comply with all the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with intolerance, contraindication or potential allergy or hypersensitivity to study drug or drugs of similar chemical class. 2. Patients with pre-existing cardiovascular and respiratory diseases. 3. Patients diagnosed with productive cough with excessive secretions, regardless of color. 4. Patients diagnosed with chronic cough (i.e., history of chronic bronchitis in smokers, gastroesophageal reflux, asthma, hyperactive responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumor, tuberculosis or fungal infections). 5. Patients using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) within 14 days prior to screening. 6. Patients receiving oral or intranasal antihistamines or cough suppressants or decongestants within 7 days prior to screening. 7. Patients with a medical history of significant disorders such as uncontrolled hypertension, uncontrolled diabetes mellitus, closed angle glaucoma, hyperthyroidism, hepatic, renal, neurologic, psychiatric, autoimmune disease, prostatic enlargement or phaeochromocytoma at screening. 8. Patients receiving monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, or other medications for depression, psychiatric, or emotional conditions, or Parkinsons disease with within 14 days prior to screening. 9. Patients who had initiation of allergen immunotherapy within 6 months prior to screening. 10. Patients with history of rhinitis medicamentosa or substantial structural nasal obstruction. 11. Patients with the presence of nasal polyps or any clinically important nasal anomaly. 12. Patients with the history of acute and/or chronic sinusitis within 30 days prior to screening. 13. Patients with the history of eye surgery or intranasal surgery within 3 months prior to screening. 14. Patients with known cases of infection with hepatitis B, hepatitis C or HIV. 15. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 16. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 17. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient s participation in the study. 18. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening. 19. Patients who are currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period. 20. Patients with suspected inability or unwillingness to comply with the study procedures. 21. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cough severity on a 100 mm visual analogue scale (VAS) score from baseline to end of the study visit (visit 4).Timepoint: Visit 1 - Screening or Baseline visit (Up to Day -1), Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in cough severity on a 100 mm visual analogue scale (VAS) score from baseline to visit 3.Timepoint: Visit 1 - Screening or Baseline visit (Up to Day -1) and Visit 3 - Follow up visit / Day 4 1.;Change in daytime cough score from baseline to visit 3 and visit 4.Timepoint: Visit 1 - Screening or Baseline visit (Up to Day -1), Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1.;Change in nighttime cough score from baseline to visit 3 and visit 4.Timepoint: Visit 1 - Screening or Baseline visit (Up to Day -1), Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1.;Change in Karolinska sleepiness scale (KSS) score from baseline to visit 3 and visit 4.Timepoint: Visit 2 - Randomization visit (Day 1), Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1.;Proportion of patients with resolution of cough at visit 3 and visit 4.Timepoint: Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1.;Patient global impression of change (PGIC) at visit 3 and visit 4.Timepoint: Visit 3 - Follow up visit / Day 4 1 and Visit 4 - End of the study visit / Day 8 1.;Adverse events and serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Up to Day -1) and Visit 4 - End of the study visit / Day 8 1. | — |
Countries
India
Contacts
Public ContactDr Pavankumar M Daultani
Zydus Healthcare Limited
Outcome results
None listed