Trial Outcomes & Findings for A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device (NCT NCT01243892)
NCT ID: NCT01243892
Last Updated: 2016-12-01
Results Overview
The annualized height velocity (cm per year \[cm/yr\]) over 2 years was calculated as: \[(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)\] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.
TERMINATED
18 participants
Baseline up to Month 24 (Year 2)
2016-12-01
Participant Flow
Due to slow enrollment, the study was terminated after screening 33 participants and enrolling only 18 participants, out of 480 planned participants.
Participant milestones
| Measure |
IGHD Participants
Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \[DNA\] origin) (recombinant human growth hormone \[rhGH\]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
ISS Participants
Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
3
|
|
Overall Study
COMPLETED
|
13
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
IGHD Participants
Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \[DNA\] origin) (recombinant human growth hormone \[rhGH\]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
ISS Participants
Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
|---|---|---|
|
Overall Study
Did not meet eligibility criteria
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Baseline characteristics by cohort
| Measure |
IGHD Participants
n=15 Participants
IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
ISS Participants
n=3 Participants
ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
9.60 Years
STANDARD_DEVIATION 2.07 • n=5 Participants
|
8.11 Years
STANDARD_DEVIATION 2.60 • n=7 Participants
|
9.35 Years
STANDARD_DEVIATION 2.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 24 (Year 2)Population: Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.
The annualized height velocity (cm per year \[cm/yr\]) over 2 years was calculated as: \[(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)\] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Month 12 (Year 1)Population: Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.
The annualized height velocity (cm/yr) after 1 year was calculated as: \[(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)\] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12 to Month 24 (Year 1 to Year 2)Population: Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.
The annualized height velocity (cm/yr) for second year was calculated as: \[(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)\] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.
Outcome measures
Outcome data not reported
Adverse Events
IGHD Participants
ISS Participants
Serious adverse events
| Measure |
IGHD Participants
n=15 participants at risk
IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
ISS Participants
n=3 participants at risk
ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
|---|---|---|
|
General disorders
Peripheral oedema
|
6.7%
1/15 • Baseline up to approximately 9 months
Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
|
0.00%
0/3 • Baseline up to approximately 9 months
Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
|
Other adverse events
| Measure |
IGHD Participants
n=15 participants at risk
IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
ISS Participants
n=3 participants at risk
ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Baseline up to approximately 9 months
Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
|
33.3%
1/3 • Baseline up to approximately 9 months
Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER