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.

Biodeal Laboratories Pvt. Ltd 508, G.I.D.C Estate, Wadhwan city, Dist Surendranagar,Gujarat - 3630350 个研究点目标入组 62 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1)Male and Females aged 18 years and over.
•2)Patients diagnosed with Central Cranial Diabetes Insipidus with any cause.
•3)No clinically significant abnormal findings in the medical history, physical exam or nasal exam.
•4)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.

•1)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.

发起方

Biodeal Laboratories Pvt. Ltd 508, G.I.D.C Estate, Wadhwan city, Dist Surendranagar,Gujarat - 363035