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

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Osteoporosis
Interventions Drug: Recombinant Salmon Calcitonin (rsCT)
Drug: Oral Tablet
Drug: Nasal Spray
Enrollment 24
Recruitment Details Subjects were recruited from the study site data base during January 2008.
Pre-assignment Details  
Arm/Group Title rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA
Hide Arm/Group Description single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
Period Title: Period 1
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Period Title: Washout 1
Started 4 4 4 4 4 4
Completed 4 4 3 3 4 4
Not Completed 0 0 1 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             1             0             0
Period Title: Period 2
Started 4 4 3 3 4 4
Completed 4 4 3 3 4 4
Not Completed 0 0 0 0 0 0
Period Title: Washout 2
Started 4 4 3 3 4 4
Completed 4 4 3 3 4 4
Not Completed 0 0 0 0 0 0
Period Title: Period 3
Started 4 4 3 3 4 4
Completed 4 4 3 3 4 4
Not Completed 0 0 0 0 0 0
Arm/Group Title rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA Total
Hide Arm/Group Description single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 4 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
2
  50.0%
3
  75.0%
4
 100.0%
4
 100.0%
4
 100.0%
21
  87.5%
>=65 years
0
   0.0%
2
  50.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
Female
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
4 4 4 4 4 4 24
1.Primary Outcome
Title Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, only subjects who completed all 3 treatments were analyzed.
Arm/Group Title rsCT A rsCTB Fortical®
Hide Arm/Group Description:
Oral rsCT (150 micrograms)
Oral rsCT (200 micrograms)
Fortical nasal spray (200 IU)
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: % Change in Baseline CTx-1
-74.17  (2.44) -71.99  (2.88) -68.40  (2.80)
Time Frame Adverse Events were collected at each study visit. The three study periods occurred at weekly intervals, so the AE data were collected over a period of 3 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA
Hide Arm/Group Description single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
All-Cause Mortality
rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rsCTA Then rsCTB Then Fortical rsCTA Then Fortical Then rsCTB rsCTB Then rsCTA Then Fortical rsCTB Then Fortical Then rsCTA Fortical Then rsCTA Then rsCTB Fortical Then rsCTB Then rsCTA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      2/4 (50.00%)      1/4 (25.00%)      1/4 (25.00%)      3/4 (75.00%)      3/4 (75.00%)    
Gastrointestinal disorders             
Diarrhea * 1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  4 1/4 (25.00%)  1 1/4 (25.00%)  1 1/4 (25.00%)  1
Nausea * 1  1/4 (25.00%)  1 2/4 (50.00%)  2 0/4 (0.00%)  0 1/4 (25.00%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0
General disorders             
Headache * 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 2/4 (50.00%)  2 2/4 (50.00%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction is that the Principal Investigator (PI) cannot without the sponsor's prior written consent, transmit, publish, or otherwise disclose to any person or entity either clinical trial results information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Wicks, Ph.D., Vice-President Global RA/QA
Organization: Tarsa Therapeutics, Inc.
Phone: 267 273 7946
EMail: twicks@tarsatherapeutics.com
Layout table for additonal information
Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00620854     History of Changes
Other Study ID Numbers: UGL-OR0702
Bio-Kinetic No.: 96508
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: April 22, 2009
Results First Posted: September 24, 2009
Last Update Posted: February 1, 2012