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

NCT ID: NCT01312831

Last Updated: 2011-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-12-31

Brief 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).

Conditions

Vitamin B 12 Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Eligen® B12

Eligen® B12 1000 μg oral tablet taken in the fasted state as a single tablet with 50 mL water. Each dose self-administered daily, for 90 days, after an overnight fast and 1 hour before the morning meal.

Group Type: EXPERIMENTAL

Vitamin B12 (cyanocobalamin)

Intervention Type: OTHER

IM B12

Commercially available 1000 μg cyanocobalamin administered IM as 1 mL from a vial containing 1000 μg/mL drug administered by study personnel, in the research clinic, in the morning, in the fasted state and at least 1 hour prior to the morning meal on study Days 1, 3, 7, 10, 14, 21, 30, 60 and 90.

Group Type: ACTIVE_COMPARATOR

Vitamin B12 (cyanocobalamin)

Intervention Type: OTHER

Interventions

Vitamin B12 (cyanocobalamin)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emisphere Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Emisphere Technologies

Principal Investigators

Benno Roesch, MD

Role: PRINCIPAL_INVESTIGATOR

Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA

Nancy Allegar, MD

Role: PRINCIPAL_INVESTIGATOR

Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA

Mitchell K. Spinnell, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA

Michael M. Rothkopf, MD

Role: PRINCIPAL_INVESTIGATOR

South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USA

Peter Varunok, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA

References

Castelli MC, Friedman K, Sherry J, Brazzillo K, Genoble L, Bhargava P, Riley MG. Comparing the efficacy and tolerability of a new daily oral vitamin B12 formulation and intermittent intramuscular vitamin B12 in normalizing low cobalamin levels: a randomized, open-label, parallel-group study. Clin Ther. 2011 Mar;33(3):358-371.e2. doi: 10.1016/j.clinthera.2011.03.003.

Reference Type: DERIVED

PMID: 21600388 (View on PubMed)

Other Identifiers

EMIS-112-C-02

Identifier Type: -

Identifier Source: org_study_id