Growth DisorderPhase 3NCT00191074
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
A Phase 3 study testing somatropin, rDNA origin, for injection in people with Growth Disorder, run by Eli Lilly and Company at 1 site in United States.
Trial summary
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Growth Disorder
- What is being tested?
- somatropin, rDNA origin, for injection
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participation in core, blinded phase and ability to be contacted by investigators.
- For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.
Who cannot join
- Diabetes mellitus.
- History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.
- Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, 20892
About this study
Official title: Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.
All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
- Conditions
- Growth Disorder
- Being tested
- somatropin, rDNA origin, for injection
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropin, rDNA origin, for injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
laboratory blood draws.
Secondary outcomes (1)
Not applicable for Amendment (g).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2001
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191074
- Sponsor's protocol ID
- 843
- Other IDs
- B9R-MC-GDCH
- Status last verified
- Mar 2007
- First submitted
- 12 Sep 2005
- Last updated
- 9 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
- ClinicalTrials.gov ID
- NCT00191074
- Acronym / sponsor ID
- 843
- Conditions
- Growth Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Study completion
- Jan 2006
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.
All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participation in core, blinded phase and ability to be contacted by investigators.
- For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.
Key exclusion criteria (3 listed)
- Diabetes mellitus.
- History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.
- Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropin, rDNA origin, for injection | Drug | – |
Primary outcome
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
laboratory blood draws.
1 secondary outcome
Not applicable for Amendment (g).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing somatropin, rDNA origin, for injection in people with Growth Disorder, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2007.