A clinical trial to study the effect 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.

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001415

Enrollment

Registered

2010-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Desmopressin Intranasal Solution BP: 0.1 to 0.4 mL daily [10 to 40 micrograms (mcg)], either as a single dose or divided into two or three doses a day. Control Intervention1: Intranasal

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To calculate and compare the reduction in mean symptoms (Polyuria, Polydipsia and Nocturia) among patients between the two groups.Timepoint: At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12	—

Secondary

Measure	Time frame
?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. Timepoint: At Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12	—

Countries

India

Contacts

Public ContactDr. Hitesh Koradia

hiteshkoradia@biodealindia.com02752243730

Outcome results