CTRI/2022/11/047227RecruitingPhase 4
A Multicentric, Phase IV Clinical Trial to Evaluate Safety and Efficacy Of Fixed Dose Combination Of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Sustained Release Suspension in Patients Suffering from Dry Cough Associated with Sneezing and/ or Running Nose and/ or Throat Irritation
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •Patient of either gender aged more than or equal to 6 years and ready to give written informed consent/assent to participate in the study at the time of screening
- •An additional written informed consent will be taken from Parent or legally acceptable representative (as applicable) in case assent is taken from patient aged more than or equal to 6 years and less than 18 years
- •Patient suffering from dry cough associated with sneezing and/or running nose and or throat irritation
- •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 at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control example combined estrogen and progestogen containing [oral, intravaginal, or transdermal]
- •or progesterone only [oral injectable or implantable] hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence)
Exclusion Criteria
- •Patient with chronic cough that occurs due to smoking, asthma or COPD or any other reasons
- •Patient with clinically significant conditions including but not limited to: pulmonary (e.g. bronchitis, bronchiectasis or asthma), central nervous system (e.g. epilepsy), severe hypertension (seated systolic >= 180 mmHg, or seated diastolic >= 110 mmHg), glaucoma, ocular hypertension (IOP > 21 mmHg), severe hepatic impairment (Child Pugh Class C) and severe renal impairment (eGFR < 15 ml/min)
- •Patient with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose
- •Malabsorption
- •Patient with history of HIV, Hepatitis B and Hepatitis C
- •Patient used any medication or herbal remedies to treat cold and cough prior to screening (antibiotics in the last 14 days, antitussive or antihistamines or decongestant or herbal remedies in the last 72 hours, medicated lozenge in the last 24 hours)
- •Patient who have used monoamine oxidase inhibitors within 14 days prior to screening
- •Patient with a history of allergic response to any of the investigational product and/or its components
- •Patient with current diagnosis of substance abuse (as per DSM-5) or history of alcohol or drug abuse
- •in the past 3 months prior to screening visit
- •Patient who has participated in another investigational study within 30 days prior to screening of this
- •study or planning to participate during the study
- •Female patient who is pregnant and /or lactating
- •Patient judged unfit for this study by investigator
- •Investigator, study personnel, sponsor representatives and their first degree relatives
- •Patient operating heavy complex machinery or who intend to drive
Investigators
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