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Trial record 17 of 239 for:    CALCITONIN SALMON

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00620854
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : September 24, 2009
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 12, 2008
First Posted Date  ICMJE February 22, 2008
Results First Submitted Date  ICMJE April 22, 2009
Results First Posted Date  ICMJE September 24, 2009
Last Update Posted Date February 1, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Plasma calcitonin and/or plasma bone resorption marker [ Time Frame: single dose crossover study ]
Change History Complete list of historical versions of study NCT00620854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Official Title  ICMJE Not Provided
Brief Summary This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • 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: Oral Tablet
    0.15 mgs recombinant salmon calcitonin, single oral dose
  • Drug: Oral Tablet
    0.2mgs recombinant salmon calcitonin, single oral tablet
  • Drug: Nasal Spray
    200 IU recombinant salmon calcitonin, single intranasal spray
Study Arms  ICMJE
  • Experimental: rsCTA
    Oral Tablet
    Intervention: Drug: Oral Tablet
  • Experimental: rsCTB
    Oral Tablet
    Intervention: Drug: Oral Tablet
  • Active Comparator: Fortical
    Nasal Spray
    Interventions:
    • Drug: Recombinant Salmon Calcitonin (rsCT)
    • Drug: Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00620854
Other Study ID Numbers  ICMJE UGL-OR0702
Bio-Kinetic No.: 96508
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tarsa Therapeutics, Inc.
Study Sponsor  ICMJE Tarsa Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Legg, D.O. Bio-Kinetic Clinical Applications, Inc.
PRS Account Tarsa Therapeutics, Inc.
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP