Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 231 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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Phase 1 Pharmacodynamic Study
Interventions Drug: Oral rsCT tablet
Drug: Oral Placebo Tablet
Drug: Fortical (rsCT) nasal spray
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Recombinant Salmon Calcitonin (rsCT) Oral Placebo Oral rsCT Tablets (Part 2, Period 3) Fortical Nasal Spray (Part 2, Period 3)
Hide Arm/Group Description In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal. In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
Period Title: Part 1, Period 1
Started 6 6 0 0
Completed 6 6 0 0
Not Completed 0 0 0 0
Period Title: Part 1, Period 2
Started 6 6 0 [1] 0 [1]
Completed 6 6 0 [2] 0 [2]
Not Completed 0 0 0 0
[1]
No subjects were to be treated until after Periods 1 and 2.
[2]
No subjects treated.
Period Title: Part 2, Period 3
Started 0 [1] 0 [2] 5 [3] 4 [4]
Completed 0 [1] 0 [2] 5 [5] 4 [5]
Not Completed 0 0 0 0
[1]
No subjects were treated in this period
[2]
No subjects were treated in this period.
[3]
Of the 6 eligible, 1 elected not to continue into Period 3.
[4]
Of the 6 eligible, 2 elected not to continue into Period 3.
[5]
All who started this period completed
Arm/Group Title Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Open Label--Oral rsCT Tablets Part 2 Open Label Fortical Intranasal Spray Total
Hide Arm/Group Description Subjects were given oral rsCT tablets 4 hours after the evening meal Subjects were given oral placebo tablets 4 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal Total of all reporting groups
Overall Number of Baseline Participants 6 6 0 0 12
Hide Baseline Analysis Population Description
Only 12 women entered Part 1, the two-period crossover portion of the study; hence the same 12 received both oral treatments and should not be counted twice. Only 9 of those 12 went on to Part 2, the open label, non-crossover portion of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
59.3  (4.7) 59.3  (4.7) 59.3  (4.7)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
Female 6 6 12
Male 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
6 6 12
post-menopausal healthy females  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
6 6 12
post-menopausal females  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
6 6 12
1.Primary Outcome
Title Pharmacodynamic Effect of Oral Calcitonin
Hide Description 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
Time Frame 12 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Not applicable. All participants who received treatment were included.
Arm/Group Title Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Oral rsCT Tablets Part 2 Fortical Intra-nasal Spray
Hide Arm/Group Description:
In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
Subjects were given oral rsCT tablets four hours after the evening meal
Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
Overall Number of Participants Analyzed 12 12 5 4
Mean (Standard Deviation)
Unit of Measure: percentage of time-matched placebo respo
37.5  (13.2) 100 [1]   (NA) 41.2  (16.6) 44.4  (21.8)
[1]
As all values were converted to 100 percent, there was no variability
2.Secondary Outcome
Title Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women
Hide Description 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).
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first.
Arm/Group Title Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Oral rsCT Tablets Part 2 Fortical Intra-nasal Spray
Hide Arm/Group Description:
In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
Overall Number of Participants Analyzed 12 12 4 5
Mean (Standard Deviation)
Unit of Measure: Hours
Tmin=time in hours to Rmin 7.5  (5.0) 0  (0) 4.5  (5.0) 4.0  (3.5)
TInhibition=total time of effect in hours 10.9  (2.0) 0  (0) 9.9  (2.6) 10.7  (3.0)
3.Secondary Outcome
Title AUCInhibition=Hours*%P
Hide Description The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.
Time Frame 12 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Oral rsCT Tablets Part 2 Fortical Intra-nasal Spray
Hide Arm/Group Description:
In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
Overall Number of Participants Analyzed 12 12 4 5
Mean (Standard Deviation)
Unit of Measure: hours*%P
474.7  (267.7) 0  (0) 345.8  (279.0) 504.7  (477.4)
Time Frame Any time within the treatment period up to 30 days after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Open Label--Oral rsCT Tablets Part 2 Open Label Fortical Intranasal Spray
Hide Arm/Group Description Subjects were given oral rsCT tablets 4 hours after the evening meal Subjects were given oral placebo tablets 4 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal. After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
All-Cause Mortality
Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Open Label--Oral rsCT Tablets Part 2 Open Label Fortical Intranasal Spray
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Open Label--Oral rsCT Tablets Part 2 Open Label Fortical Intranasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/5 (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%
Part 1 Oral rsCT Tablets Part 1 Oral Placebo Tablets Part 2 Open Label--Oral rsCT Tablets Part 2 Open Label Fortical Intranasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      3/12 (25.00%)      0/5 (0.00%)      1/4 (25.00%)    
Gastrointestinal disorders         
abdominal pain upper * 2  0/12 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain in extremity * 2  0/12 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
eyelid edema * 2  0/12 (0.00%)  0 1/12 (8.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders         
Headache * 2  1/12 (8.33%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Nasal Congestion * 1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRRA 12.1
2
Term from vocabulary, MedDRA 12.1
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.
Except as provided herein or as required by applicable law, you agree that you shall keep such Unigene Information confidential and that you shall not, without our prior written consent, transmit, publish, or otherwise disclose to any person or entity either (i) the Unigene Information, (ii) the fact of our disclosure of the Unigene Information to you, or (iii) the existence or terms of any negotiations or discussions between us regarding your potential engagement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicholas LaBella, Jr. Vice-President Global RA/QA
Organization: Tarsa Therapeutics, Inc
Phone: 267-273-7944
EMail: nlabella@tarsatherapeutics.com
Layout table for additonal information
Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00803686     History of Changes
Other Study ID Numbers: UGL-OR0803
Bio-Kinetic No.: 13808 ( Other Identifier: Unigene Laboratories 0803 )
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: January 14, 2010
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014