CTRI

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CTRI Number

CTRI/2015/06/005952 [Registered on: 30/06/2015] Trial Registered Prospectively

Last Modified On:

04/01/2018

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

A clinical study evaluating the safety and efficacy of intranasal methylcobalamin for therapy of vitamin B12 deficiency.

Scientific Title of Study

An open label, single arm, multicentric study evaluating the safety and efficacy of intranasal methylcobalamin for treatment and maintenance therapy of vitamin B12 deficiency.

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
CT/31/01/12 Version 01 Amendement 03 Dated 15 June 2015	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sanjaykumar Maroo
Designation	Sr. GM, Medical Services
Affiliation	Troikaa Pharmaceuticals Limited
Address	Commerce House 1, Opp Rajvansh Tower Off. Judges Bunglows, Ahmedabad. Ahmadabad GUJARAT 380054 India
Phone	07926856242
Fax	07926856246
Email	sanjaymaroo@troikaapharma.com

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Amarinder Singh
Designation	GM-Medical Services
Affiliation	Troikaa Pharmaceuticals Limited
Address	Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad Ahmadabad GUJARAT 380054 India
Phone	07926856242
Fax	07926856246
Email	amarindersingh@troikaapharma.com

Details of Contact Person
Public Query
Modification(s)

Name	Dr Amarinder Singh
Designation	GM-Medical Services
Affiliation	Troikaa Pharmaceuticals Limited
Address	Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad Ahmadabad GUJARAT 380054 India
Phone	07926856242
Fax	07926856246
Email	amarindersingh@troikaapharma.com

Source of Monetary or Material Support

Troikaa Pharmaceuticals Limited, Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows, Ahmedabad 380054, Gujarat

Primary Sponsor

Name	Troikaa Pharmaceuticals Limited
Address	Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows, Ahmedabad 380054, Gujarat
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 8
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Tulika Sheth	All India Institute of Medical Sciences (AIIMS), Delhi	Department of Hematology, All India Institute of Medical Sciences (AIIMS) Ansari Nagar, Delhi New Delhi - 110029 New Delhi DELHI	9868397236 tulisheth@yahoo.com
Dr Debasis Basu	Apollo Gleneagles Hospitals, Kolkata	Department of Clinical Trial and Research 58 Canal Circular Road ,Kolkata-700054 West Bengal Kolkata WEST BENGAL	9952087573 drdbasu@yahoo.com
Dr Dushyant Balat	Apollo Hospitals International Ltd, Gandhinagar	Plot no 1A, Bhat, GIDC Estate, Gandhinagar-382428 Gandhinagar GUJARAT	9033461600 drdushyant_balat@hotmail.com
Dr P Prabu	Apollo Hospitals, Chennai	21, Greams Lane, Off Greams Road, Chennai - 600006 Chennai TAMIL NADU	7708878871 drprabu.p@gmail.com
Dr Ajay Agarwal	Fortis Hospital Noida	B-22, Sector 62, Gautam Buddh Nagar, Noida, Uttar Pradesh 201301 Gautam Buddha Nagar UTTAR PRADESH	9810258977 ajay.agarwal@fortishealthcare.com
Dr Prantar Chakrabarti	Nil Ratan Sircar Medical College & Hospital, Kolkata	Raja Bazar, Kolkata 700014 Kolkata WEST BENGAL	9433018899 prantar@gmail.com
Dr Vikas Suri	PGIMER, Chandigarh	Department of Internal Medicine, Post-Graduate Institute of Medical Education & Research (PGIMER) Chandigarh - 160012 Chandigarh CHANDIGARH	7087009683 surivikas9479@gmail.com
Dr Sachin	Sapthagiri Institute of Medical Sciences and Research Center	Department of General Medicine, Sapthagiri Institute of Medical Sciences and Research Center, #15, Chikkasandra, Hesaraghatta Main Road, Bangalore-560 090Â Bangalore KARNATAKA	8904523423 drsachinmurthy9@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 9
Name of Committee	Approval Status
Ethics Committee - Apollo Hospitals International Ltd	Approved
Ethics Committee â€“ Apollo Hospitals, Chennai	Approved
Ethics Committee, All India Institute of Medical Sciences, Delhi	Approved
Ethics Committee, N.R.S. Medical College	Approved
Ethics Committee, Sapthagiri Institute of Medical Sciences and Reserach Center, Bangalore	Approved
Fortis Hospital Institutional Ethics Committee, Noida	Approved
Institutional Ethics Committee (IEC) Apollo Gleneagles Hospital, Kolkata	Approved
Institutional Ethics Committee Peerless Hospital and B.K Roy Research Centre	Approved
Institutional Ethics Committee, PGIMER, Chandigarh	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Vitamin B12 deficiency,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Methylcobalamin Nasal Spray 250 mcg per puff	Treatment phase: 1 puff in each nostril, total two puffs at a time on alternate days for 2 weeks e.g. 7 doses. Maintenance phase: 1 puff in each nostril, total two puffs at a time, once in a week for 4 weeks e.g. 4 doses.
Comparator Agent	NA	NA

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1. Patients of either sex in the age group of 18-55 years 2. Patients with serum vitamin B12 levels less than 200 pg/ml at the time of screening. 3. Patients willing to give written informed consent prior to participation in the study.

ExclusionCriteria

Details

1. Patients with known hypersensitivity or allergies to cobalt and/or Vitamin B12 or any component of the medication.
2. Patients with serum folate < 3ng/ml during screening (or below reference range of laboratory).
3. Patient with severe anaemia defined as Haemoglobin < 7 gm/dl.
4. Patients with history of or diagnosed with thrombocytopenia, leucopenia, pancytopenia or any other haematological malignancy.
5. Patients with history of recurrent or current abuse of alcohol
6. Patients with signs or symptoms of neurological involvement.
7. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
8. Patient using any transnasal/ intranasal medication.
9. Patients having renal insufficiency. (serum creatinine > 1.2 mg/dl)
10. Patients on treatment with drugs which interfere with folate metabolism or interfere with folic acid and vitamin B12 assay.
11. Female patients who are pregnant or planning to conceive or nursing
12. Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening.
13. Patients having any other clinically significant systemic condition that is life threatening, or in the opinion of the investigator, does not justify their inclusion in the study.
14. Patient not having facility for telephonic communication.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1) Proportion of patients achieving vitamin B12 levels greater than 200pg/ml 2) Proportion of patients maintaining their vitamin B12 level greater than 200pg/ml	1) End of 2 weeks 2) End of 6 weeks

Secondary Outcome

Outcome

TimePoints

1) Vitamin B12 levels as compared to baseline vitamin B12 levels.
2) Vitamin B12 levels as compared to vitamin B12 levels at end of 2 weeks.
3) Serum methylcobalamin levels as compared to baseline.
4) Hemoglobin values as compared to baseline.
5) Physicianâ€™s global assessment
6) Treatment emergent adverse events â€“ incidence and severity
7) Abnormality in vital signs and physical examination
8) Global tolerability at end of study

1) At end of 1st and 2nd week
2) at end of 4th and 6th week
3) at week 2 and 6
4) at week 1, 2, 4 and 6
5) at end of treatment
6) Throughout the study
7) Throughout the study
8) End of treatment

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="103"

Phase of Trial

Phase 3

Date of First Enrollment (India)
Modification(s)

24/08/2015

Date of Study Completion (India)

14/07/2017

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Currently, methylcobalamin is available as an intramuscular injection in several countries including India. Intranasal formulation is not available anywhere in the world. So, availability of intranasal methylcobalamin in India would be beneficial in terms of therapeutic efficacy, convenience, cost and compliance in patients with vitamin B₁₂ deficiency.

Troikaa Pharmaceuticals Limited has developed an innovative Methylcobalamin Nasal Spray (Intranasal MethylCobalamin) 250 Âµg/ puff, which is not available anywhere in the world. The present study aims to evaluate efficacy & safety of Troikaaâ€™s test formulation in Adult Patients vitamin B12 deficiency.

The primary objective of this study is to evaluate the safety and efficacy of intranasal methylcobalamin in treatment and maintenance therapy of vitamin B₁₂ deficiency in patients without neurological symptoms.