Trial record 3 of 5 for:
tarsa
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
This study has been completed.
Sponsor:
Tarsa Therapeutics, Inc.
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00620854
First received: February 12, 2008
Last updated: January 30, 2012
Last verified: January 2012
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Purpose
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: Recombinant Salmon Calcitonin (rsCT) Drug: Oral Tablet Drug: Nasal Spray |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
Resource links provided by NLM:
Further study details as provided by Tarsa Therapeutics, Inc.:
Primary Outcome Measures:
- Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB ] [ Designated as safety issue: No ]This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.
| Enrollment: | 24 |
| Study Start Date: | February 2008 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rsCTA
Oral Tablet
|
Drug: Oral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose
|
|
Experimental: rsCTB
Oral Tablet
|
Drug: Oral Tablet
0.2mgs recombinant salmon calcitonin, single oral tablet
|
|
Active Comparator: Fortical
Nasal Spray
|
Drug: Recombinant Salmon Calcitonin (rsCT)
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
Other Name: Fortical® nasal spray
Drug: Nasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray
|
Eligibility| Ages Eligible for Study: | 45 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Postmenopausal female, in good health (at least 5 years since last menses)
- Age ≥45 and ≤70
- Weight + or - 20% of the Metropolitan Life weight table
- Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
- Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
- Willing and able to comply with all study requirements
- Willing and able to sign written informed consent
- Negative urine pregnancy test at screening
- Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse
Exclusion Criteria:
- History of parathyroid, thyroid, pituitary or adrenal diseases
- History of musculoskeletal disease
- History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
- History of cancer within 5 years of enrollment other than basal cell carcinoma
- History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
- History of surgery within 60 days of enrollment
- History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
- Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
- Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
- Presence of any clinically significant illness
- Unwilling or unable to comply with all study requirements
- Unwilling or unable to sign written, informed consent
- History of drug or alcohol abuse
- Participation in any clinical study of an investigational drug within 60 days of enrollment
- Plasma CTx-1 less than 0.25 ng/mL
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620854
Locations
| United States, Missouri | |
| Bio-Kinetic Clinical Applications, Inc. | |
| Springfield, Missouri, United States, 65802 | |
Sponsors and Collaborators
Tarsa Therapeutics, Inc.
Investigators
| Principal Investigator: | Thomas Legg, D.O. | Bio-Kinetic Clinical Applications, Inc. |
More Information
No publications provided
| Responsible Party: | Tarsa Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00620854 History of Changes |
| Other Study ID Numbers: | UGL-OR0702, Bio-Kinetic No.: 96508 |
| Study First Received: | February 12, 2008 |
| Results First Received: | April 22, 2009 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Salmon calcitonin Calcitonin Calcitonin Gene-Related Peptide |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013