“A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Noscapine and Chlorpheniramine Maleate Oral Syrup in Patients for the Treatment of Dry, Irritating Cough Associated with Running Nose.â€
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 12
- 主要终点
- Mean change in cough severity score (CSS) from baseline to end of the study visit.
研究概览
简要总结
Thistrial is a phase III, prospective, randomized, double blind, active-controlled,comparative, parallel group, multicentric clinical study to evaluate the efficacy,safety and tolerability of FDC of Noscapine and Chlorpheniramine Maleate OralSyrup in patients for the treatment of dry, irritating cough associated with runningnose.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent / Assent Form on the day of screening / baseline visit (Visit1). During this screening period, patients who are willing to give consent /assent will be evaluated for all the eligibility criteria. Eligible patientswith a diagnosis of dry, irritating cough associatedwith running nose at screening visit will be considered for the study.
After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on day 3 and day 7(±1) (Final Visit) oftreatment to assess efficacy, safety and tolerability.
Patientswill be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDCof Noscapine 15 mg + Chlorpheniramine Maleate 4 mg Oral Syrup or FDC ofDextromethorphan 10 mg + Chlorpheniramine Maleate 4 mg Oral Syrup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 12 to 65 years (both inclusive).
- •Patients with a diagnosis of dry, irritating cough associated with running nose at screening visit.
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening / baseline visit.
- •Patient with ability to understand and provide written informed consent / assent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements throughout the study.
排除标准
- •Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Patients who had initiation of allergen immunotherapy within previous 6 months.
- •Patients with history of Rhinitis medicamentosa or substantial structural nasal obstruction.
- •Patients with the presence of nasal polyps or any clinically important nasal anomaly.
- •Patients with the history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
- •Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
- •Patients with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
- •Female patients who are not ready to use acceptable contraceptive methods during the study.
- •Patients with known case of HIV, Hepatitis B & C.
- •Patients with medical history of oncological conditions.
- •Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
- •Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •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.
结局指标
主要结局
Mean change in cough severity score (CSS) from baseline to end of the study visit.
时间窗: At Visit 1 / Day 1 and Visit 3 / Day 7.
次要结局
- Runny nose severity assessment from baseline to end of the study visit.(At Visit 1 / Day 1 and Visit 3 / Day 7.)
- Change in Leicester Cough Questionnaire (LCQ) from baseline to end of the study visit.(At Visit 1 / Day 1 and Visit 3 / Day 7.)
- Mean change in cough severity score (CSS) from baseline to day 3.(At Visit 1 / Day 1 and Visit 2 / Day 3.)
- Changes in clinical laboratory parameters from baseline to end of the study visit.(At Visit 1 / Day 1 and Visit 3 / Day 7.)
- Adverse events or Serious adverse events reported during the study.
- Percentage change in cough severity score (CSS) from baseline to day 3 and end of the study visit.(At Visit 1 / Day 1, Visit 2 / Day 3 and Visit 3 / Day 7.)