A Prospective, Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desmopressin Intranasal Solution BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Desmopressin Intranasal Solution BP (Mfd. by Ferring Pharmaceuticals Ltd.) in patients diagnosed with Central Cranial Diabetes Insipidus.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- To calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups.
研究概览
简要总结
the study is a A Prospective, Comparative, Randomized, Double blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desmopressin Intranasal Solution BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Desmopressin Intranasal Solution BP (Mfd. by Ferring Pharmaceuticals Ltd.) in patients diagnosed with Central Cranial Diabetes Insipidus for 12 weeks in 62 patients that will be conducted in eight centers in India. The primary outcome measures will be to calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups. The Secondary outcome measures will be to assess Global evaluation of efficacy and tolerability between two groups at the end of treatment and to analyze the rate and incidence of adverse events among patients between the two groups.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
入选标准
- •Male and Females aged 18 years and over.
- •Patients diagnosed with Central Cranial Diabetes Insipidus with any cause.
- •No clinically significant abnormal findings in the medical history, physical exam or nasal exam.
- •Patients must give written informed consent after reading the Patient Information and Consent Form and having had the opportunity to discuss the study with the Investigator.5)Patient willing to follow up and comply with the Protocol requirements.
排除标准
- •Patients with other forms of Diabetes Insipidus and Diabetes Mellitus.2)Patient not willing to participate in the trial or not in position to give the informed consent.3)Pregnant or lactating females.4)Participation in any other clinical trial involving investigational products within 30 days of screening.5)Individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Intranasal Solution.6)Patients with moderate to severe renal impairment (defined as a Creatinine clearance below 50ml/min).7)Patients with hyponatremia or a history of hyponatremia.8)Patients with medical history, especially: high blood pressure, breathing problems, nasal congestion, heart disease, fluid or vitamin/mineral (electrolyte) imbalances, any drug allergies.9)Patients using substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia.
- •NSAIDs may induce water retention and/or hyponatraemia.
结局指标
主要结局
To calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups.
时间窗: At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12
次要结局
- ?To assess Global evaluation of efficacy and tolerability between two groups at the end of treatment.?To analyze the rate and incidence of adverse events among patients between the two groups.(At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12)