An open label, single arm, multicentric study evaluating the safety and efficacy of intranasal methylcobalamin for treatment and maintenance therapy of vitamin B12 deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- 1) Proportion of patients achieving vitamin B12 levels greater than 200pg/ml
研究概览
简要总结
Currently, methylcobalaminis available as an intramuscular injection in several countries includingIndia. Intranasal formulation is not available anywhere in the world. So,availability of intranasal methylcobalamin in India would be beneficial interms of therapeutic efficacy, convenience, cost and compliance in patientswith vitamin B12deficiency.
Troikaa Pharmaceuticals Limited has developed an innovative Methylcobalamin Nasal Spray (Intranasal MethylCobalamin) 250 µg/ puff, which is not available anywhere in the world. The present study aims to evaluate efficacy & safety of Troikaa’s test formulation in Adult Patients vitamin B12 deficiency.
Theprimary objective of this study is toevaluate the safety and efficacy of intranasal methylcobalamin in treatment andmaintenance therapy of vitamin B12 deficiency in patients withoutneurological symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 18-55 years
- •Patients with serum vitamin B12 levels less than 200 pg/ml at the time of screening.
- •Patients willing to give written informed consent prior to participation in the study.
排除标准
- •Patients with known hypersensitivity or allergies to cobalt and/or Vitamin B12 or any component of the medication.
- •Patients with serum folate < 3ng/ml during screening (or below reference range of laboratory).
- •Patient with severe anaemia defined as Haemoglobin < 7 gm/dl.
- •Patients with history of or diagnosed with thrombocytopenia, leucopenia, pancytopenia or any other haematological malignancy.
- •Patients with history of recurrent or current abuse of alcohol
- •Patients with signs or symptoms of neurological involvement.
- •Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
- •Patient using any transnasal/ intranasal medication.
- •Patients having renal insufficiency.
- •(serum creatinine > 1.2 mg/dl)
- •Female patients who are pregnant or planning to conceive or nursing
- •Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening.
- •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.
- •Patient not having facility for telephonic communication.
结局指标
主要结局
1) Proportion of patients achieving vitamin B12 levels greater than 200pg/ml
时间窗: 1) End of 2 weeks | 2) End of 6 weeks
2) Proportion of patients maintaining their vitamin B12 level greater than 200pg/ml
时间窗: 1) End of 2 weeks | 2) End of 6 weeks
次要结局
- 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.)