Trial Outcomes & Findings for A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women (NCT NCT00620854)
NCT ID: NCT00620854
Last Updated: 2012-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
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
Results posted on
2012-02-01
Participant Flow
Subjects were recruited from the study site data base during January 2008.
Participant milestones
| Measure |
rsCTA Then rsCTB Then Fortical
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTA Then Fortical Then rsCTB
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then rsCTA Then Fortical
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then Fortical Then rsCTA
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTA Then rsCTB
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTB Then rsCTA
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period 1
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Washout 1
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Washout 1
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Period 2
STARTED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Period 2
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2
STARTED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Washout 2
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Washout 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Period 3
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
rsCTA Then rsCTB Then Fortical
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTA Then Fortical Then rsCTB
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then rsCTA Then Fortical
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then Fortical Then rsCTA
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTA Then rsCTB
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTB Then rsCTA
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
|---|---|---|---|---|---|---|
|
Washout 1
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Baseline characteristics by cohort
| Measure |
rsCTA Then rsCTB Then Fortical
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTA Then Fortical Then rsCTB
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then rsCTA Then Fortical
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then Fortical Then rsCTA
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTA Then rsCTB
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTB Then rsCTA
n=4 Participants
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
4 participants
n=31 Participants
|
4 participants
n=30 Participants
|
24 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 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 rsCTBPopulation: Per protocol, only subjects who completed all 3 treatments were analyzed.
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.
Outcome measures
| Measure |
rsCT A
n=22 Participants
Oral rsCT (150 micrograms)
|
rsCTB
n=22 Participants
Oral rsCT (200 micrograms)
|
Fortical®
n=22 Participants
Fortical nasal spray (200 IU)
|
|---|---|---|---|
|
Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
|
-74.17 % Change in Baseline CTx-1
Standard Error 2.44
|
-71.99 % Change in Baseline CTx-1
Standard Error 2.88
|
-68.40 % Change in Baseline CTx-1
Standard Error 2.80
|
Adverse Events
rsCTA Then rsCTB Then Fortical
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rsCTA Then Fortical Then rsCTB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
rsCTB Then rsCTA Then Fortical
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rsCTB Then Fortical Then rsCTA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Fortical Then rsCTA Then rsCTB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fortical Then rsCTB Then rsCTA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rsCTA Then rsCTB Then Fortical
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTA Then Fortical Then rsCTB
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then rsCTA Then Fortical
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
rsCTB Then Fortical Then rsCTA
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTA Then rsCTB
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
Fortical Then rsCTB Then rsCTA
n=4 participants at risk
single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
25.0%
1/4 • Number of events 4 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
|
General disorders
Headache
|
0.00%
0/4 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
50.0%
2/4 • Number of events 2 • 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.
|
50.0%
2/4 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 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.
|
50.0%
2/4 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
25.0%
1/4 • Number of events 2 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
Additional Information
Thomas Wicks, Ph.D., Vice-President Global RA/QA
Tarsa Therapeutics, Inc.
Phone: 267 273 7946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER