Brain InjuriesPhase 4NCT00432263
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
A Phase 4 study testing Genotropin (PN-180,307) Somatropin in people with Brain Injuries, run by Pfizer.
Trial summary
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Genotropin (PN-180,307) Somatropin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to not given
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit.
- Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
Who cannot join
- Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
- Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
About this study
Official title: Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
- Conditions
- Brain Injuries
- Being tested
- Genotropin (PN-180,307) Somatropin
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotropin (PN-180,307) SomatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
Secondary outcomes (1)
Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432263
- Sponsor's protocol ID
- A6281274
- Status last verified
- Apr 2015
- First submitted
- 5 Feb 2007
- Last updated
- 22 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00432263
- Acronym / sponsor ID
- A6281274
- Conditions
- Brain Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- First posted
- 7 Feb 2007 (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.
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit.
- Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
Key exclusion criteria (2 listed)
- Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
- Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
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 |
|---|---|---|
| Genotropin (PN-180,307) Somatropin | Drug | – |
Primary outcome
The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
1 secondary outcome
Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genotropin (PN-180,307) Somatropin in people with Brain Injuries, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.. 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 22 Apr 2015.