Trial · NCT00630487
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
NCT00630487, Phase 3, Terminated, Pfizer; results first posted 2011-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency. Trials, record NCT00630487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00630487
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
- NCT number
- NCT00630487
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Growth Hormone Deficiency
- Interventions
- Placebo, Somatropin
- First posted
- 2008-03-07
- Last updated
- 2013-03-04
- Results first posted
- 2011-01-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI) | Baseline, 52 weeks | Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra. |
| Secondary | Change in Visceral Fat Mass in Subgroups | Baseline, 52 weeks, 78 weeks | Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). |
| Secondary | Change From Baseline in Anthropometric Parameters (Height) | Baseline, 52 weeks, 78 weeks | |
| Secondary | Change From Baseline in Anthropometric Parameters (Weight) | Baseline, 52 weeks, 78 weeks | |
| Secondary | Change From Baseline in Anthropometric Parameters (Waist Circumference) | Baseline, 52 weeks, 78 weeks | |
| Secondary | Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT]) | Baseline, Week 52, Week 78 | Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning). |
| Secondary | Change From Baseline in Blood Pressure | Baseline, Week 52, Week 78 | Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure. |
| Secondary | Change From Baseline in Heart Rate | Baseline, Week 52, Week 78 | The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds. |
| Secondary | Change in Executive Function and Memory in Subgroups | Baseline, Week 52, Week 78 | Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions. |
| Secondary | Change From Baseline in Safety Laboratory Assessments | Baseline, Week 52, Week 78 | Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI) | Baseline, 52 weeks | Study terminated, no subjects were treated. | ||
| SECONDARY | Change in Visceral Fat Mass in Subgroups | Baseline, 52 weeks, 78 weeks | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Anthropometric Parameters (Height) | Baseline, 52 weeks, 78 weeks | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Anthropometric Parameters (Weight) | Baseline, 52 weeks, 78 weeks | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Anthropometric Parameters (Waist Circumference) | Baseline, 52 weeks, 78 weeks | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT]) | Baseline, Week 52, Week 78 | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Blood Pressure | Baseline, Week 52, Week 78 | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Heart Rate | Baseline, Week 52, Week 78 | Study terminated, no subjects were treated. | ||
| SECONDARY | Change in Executive Function and Memory in Subgroups | Baseline, Week 52, Week 78 | Study terminated, no subjects were treated. | ||
| SECONDARY | Change From Baseline in Safety Laboratory Assessments | Baseline, Week 52, Week 78 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | STARTED | Somatropin | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Somatropin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Somatropin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Somatropin | ||
| Total, other adverse events | Placebo | 0 | 0 |
| Total, other adverse events | Somatropin | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Somatropin | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Secondary outcome | ConductCognition |
| Word Span Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00630487
GET https://conductscience.org/api/trials/v1/NCT00630487/registered