Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin
This study has been completed.
Sponsor:
Emisphere Technologies, Inc.
Information provided by:
Emisphere Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01312831
First received: March 4, 2011
Last updated: March 9, 2011
Last verified: March 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Vitamin B 12 Deficiency |
Other: Vitamin B12 (cyanocobalamin) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Emisphere Technologies, Inc.:
Primary Outcome Measures:
- Serum Cobalamin Normalization [ Time Frame: 61 days ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Maintenance of B12 Normalization [ Time Frame: 91 days ] [ Designated as safety issue: No ]Maintenance of cobalamin normalization after 90 days of treatment
- Time to Normalization [ Time Frame: 90 days ] [ Designated as safety issue: No ]Time to normalization of cobalamin levels
- Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment [ Time Frame: 91 days ] [ Designated as safety issue: No ]
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.
- Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment [ Time Frame: 91 days ] [ Designated as safety issue: No ]
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
- Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment [ Time Frame: 91 days ] [ Designated as safety issue: No ]
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
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 91 days ] [ Designated as safety issue: No ]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.
- Holo-trancobalamin (holo-TC) Normalization [ Time Frame: 91 days ] [ Designated as safety issue: No ]The proportion of subjects who achieve normalization of holo-TC levels (≥ 40 pmol/L) on Days 61 and 91 as an exploratory endpoint
- Holo-TC and Cobalamin Correlation [ Time Frame: 91 days ] [ Designated as safety issue: No ]Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint
| Enrollment: | 49 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Other: Vitamin B12 (cyanocobalamin) |
|
Active Comparator: 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.
|
Other: Vitamin B12 (cyanocobalamin) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312831
Sponsors and Collaborators
Emisphere Technologies, Inc.
Investigators
| Principal Investigator: | Benno Roesch, MD | Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA |
| Principal Investigator: | Nancy Allegar, MD | Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA |
| Principal Investigator: | Mitchell K. Spinnell, MD | Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA |
| Principal Investigator: | Michael M. Rothkopf, MD | South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USA |
| Principal Investigator: | Peter Varunok, MD | Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA |
More Information
No publications provided by Emisphere Technologies, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M. Cristina Castelli, Ph.D., Emisphere Technologies |
| ClinicalTrials.gov Identifier: | NCT01312831 History of Changes |
| Other Study ID Numbers: | EMIS-112-C-02 |
| Study First Received: | March 4, 2011 |
| Last Updated: | March 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emisphere Technologies, Inc.:
|
cobalamin B12 homocysteine |
MMA holotranscobalamin Eligen |
Additional relevant MeSH terms:
|
Vitamin B 12 Deficiency Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hydroxocobalamin Vitamin B 12 Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013