Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin

Vitamin B 12 Deficiency Clinical Trial

Official title:

A 60-DAY, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Eligen® B12 OR Intramuscularly Administered B12 in Subjects With Low Serum Cobalamin With a 30 Day Extension to 90 Days of Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312831
• Other study ID #: EMIS-112-C-02
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: March 9, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Emisphere Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL

• Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).

• General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula

Exclusion Criteria:

• Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;

• Daily use of neutralizing antacids (e.g. Maalox®)

• Inability to ingest oral medication

• Clinically significant laboratory value at screening

• Hypersensitivity or allergic reaction to vitamin B12

• Participation in a clinical research study involving a new chemical entity within 30 days of the first study dose

• Folate levels below the reference range provided by the clinical laboratory.

• Renal insufficiency

• Vitamin B6 deficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Other:
• Vitamin B12 (cyanocobalamin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emisphere Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Cobalamin Normalization	The primary efficacy outcome compares the proportion of subjects in each treatment arm in whom cobalamin levels are normalized (i.e., cobalamin = 350 ng/mL) following 60 days of treatment	61 days	No
Secondary	Maintenance of B12 Normalization	Maintenance of cobalamin normalization after 90 days of treatment	91 days	No
Secondary	Time to Normalization	Time to normalization of cobalamin levels	90 days	No
Secondary	Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment	Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of cobalamin (pg/mL) and X is the measurement of cobalamin(pg/mL) at Day 61 or Day 91, as required.; Percent change from baseline is defined as 100(X-B)/B.	91 days	No
Secondary	Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment	Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of MMA (ng/mL) and X is the measurement of MMA (ng/mL) at Day 61 or Day 91, as required.; Percent change from baseline is defined as 100(X-B)/B	91 days	No
Secondary	Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment	Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of homocysteine (umol/L) and X is the measurement of homocysteine (umol/L) at Day 61 or Day 91, as required.; Percent change from baseline is defined as 100(X-B)/B	91 days	No
Secondary	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	The safety and tolerability of Eligen® B12 and intramuscular B12 assessed by physical examination findings, clinical laboratory test results, vital signs, 12-lead ECG results and adverse event reporting.	91 days	No
Secondary	Holo-trancobalamin (holo-TC) Normalization	The proportion of subjects who achieve normalization of holo-TC levels (= 40 pmol/L) on Days 61 and 91 as an exploratory endpoint	91 days	No
Secondary	Holo-TC and Cobalamin Correlation	Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint	91 days	No