CTRI/2024/04/066019
Completed
Phase 4
A Prospective, Open-Label, randomized, Clinical study to compare the efficacy and safety of novel Methylcobalamin Nasal Spray with Sublingual Methylcobalamin Tablet in the treatment of subjects with vitamin B12 deficiency.
Troikaa Pharmaceuticals Limited1 site in 1 country30 target enrollmentStarted: April 29, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1. Comparison of change in Vitamin B12 levels on day 1 [i.e. after first dose of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].
Overview
Brief Summary
This clinical trial is a prospective, open label, randomized, clinical study to compare the efficacy and safety. A total 30 Male and Female subjects, whose Vitamin B12 level is <200pg/mL will be enrolled.
Subject will be screened according to the study inclusion and exclusion criteria within 2 weeks prior to randomization (Day 0). Subject meeting all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. Subjects who provide informed consent to participate in the study will be randomized either to the Methylcobalamin NASO B12 Spray or Sublingual Methylcobalamin Tablet in a 1:1 ratio. Each group will consist of 15 randomized subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients of either gender in the age group of 18 years and above.
- •2 Vitamin B12 level less than 200 pg/mL.
- •3 Willing and able to comply with study requirements, e.g. study drug administration and study visit schedule and willing to fill patient dairy, as indicated by written informed consent provided by the patient.
- •4 The female subjects who are of non-childbearing potential (or of childbearing potential, and who have a negative urine pregnancy test at screening and willing to maintain reliable birth control throughout the study) and non-lactating.
Exclusion Criteria
- •1 Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
- •2 Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
- •3 Subjects suspected to have illnesses, where Vitamin B12 supplementation is contraindicated.
- •4 Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
- •5 Patients on treatment with drugs that interfere with Vitamin B12 assay.
- •6 Patient using any other nasal medication/device.
- •7 Pregnant and / or Lactating Women 8 Patients having participated in any clinical trial within last 30 days at the time of screening.
- •9 Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
Outcomes
Primary Outcomes
1. Comparison of change in Vitamin B12 levels on day 1 [i.e. after first dose of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].
Time Frame: on Day 1
Secondary Outcomes
- 1. Comparison of change in Vitamin B12 levels on day 6 [i.e. after 03 doses of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].(2. Proportion of subjects achieving Vitamin B12 levels ≥ 400pg/mL on day 1 for both the treatment groups.)
Investigators
Dr Banshi Saboo
Diabetes Care and Hormone Clinic
Study Sites (1)
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