Trial record 3 of 6 for:    tarsa

A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014