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Trial record 4 of 247 for:    CALCITONIN SALMON

A Study of Oral Calcitonin Given at Night to 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: NCT00803686
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2008
First Posted Date  ICMJE December 5, 2008
Results First Submitted Date  ICMJE January 14, 2010
Results First Posted Date  ICMJE June 9, 2014
Last Update Posted Date June 9, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2014)
Pharmacodynamic Effect of Oral Calcitonin [ Time Frame: 12 hr ]
C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
CTx-1 [ Time Frame: Pre-dose to 12 hours post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2014)
  • Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women [ Time Frame: 12 hours ]
    See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition).
  • AUCInhibition=Hours*%P [ Time Frame: 12 Hours ]
    The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.
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 Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Official Title  ICMJE A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
Brief Summary This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.
Detailed Description Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Phase 1 Pharmacodynamic Study
Intervention  ICMJE
  • Drug: Oral rsCT tablet
    On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.
    Other Name: rsCT
  • Drug: Oral Placebo Tablet
    Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
    Other Name: Placebo
  • Drug: Oral rsCT tablet
    Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
  • Drug: Fortical (rsCT) nasal spray
    Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
    Other Name: Fortical nasal spray
Study Arms  ICMJE
  • Experimental: Part 1 Double Blind Oral rsCT Tablet
    Intervention: Oral rsCT tablet given once 4 hours after evening meal.
    Intervention: Drug: Oral rsCT tablet
  • Placebo Comparator: Part 1, Double-blind Oral Placebo Tablet
    Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal
    Intervention: Drug: Oral Placebo Tablet
  • Experimental: Part 2 Open label, Oral rsCT tablet
    Intervention: Oral rsCT tablet given once 2 hours after evening meal.
    Intervention: Drug: Oral rsCT tablet
  • Active Comparator: Part 2, Open Label Fortical Nasal Spray
    Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal
    Intervention: Drug: Fortical (rsCT) 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: December 4, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Postmenopausal female, in good health (at least five years since last menses).
  • Age greater than or equal to 45 years old and less than or equal to 70 years old
  • Weight ± 20% of the Metropolitan Life weight table.
  • Plasma CTx-1 greater than or equal to 0.25 ng/ml.
  • Total calcium, phosphorus, and magnesium 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, 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 a Non-Steroidal Anti-inflammatory Drug (NSAID).
  • History of surgery within 60 days of enrollment.
  • History of hypersensitivity or allergies (other than seasonal allergies) within -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, 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 NCT00803686
Other Study ID Numbers  ICMJE UGL-OR0803
Bio-Kinetic No.: 13808 ( Other Identifier: Unigene Laboratories 0803 )
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 June 2014

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