Trial · NCT00766038

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

NCT00766038, Phase 2, Completed, University of Pennsylvania; results first posted 2019-11-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury. Trials, record NCT00766038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00766038

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
NCT number: NCT00766038
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Traumatic Brain Injury
Interventions: Recombinant human Growth Hormone, Placebo
First posted: 2008-10-03
Last updated: 2019-11-18
Results first posted: 2019-11-18

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index	6 months	Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal
Secondary	IGF-1 Levels.	4 years	Serum levels of Insulin-Like Growth Factor-1.
Secondary	Processing Speed Index 1 Year After Injury	1 year	Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal
Secondary	GH Response to L-arginine Stimulation at Baseline	1 day	Measurement of serum GH levels over 90 minutes after administration of L-arginine
Secondary	IGF-1 Levels	Baseline	Serum IGF-1 levels at baseline for both treatment groups was correlated with the Processing Speed Index recorded at baseline, using Pearson's correlation coefficient. Perason's correlation coefficient is a measure of the linear correlation between two variables X and Y. It has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Secondary	Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.	4 years	Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index	6 months	Processing speed index standardized scor	MEDIAN
SECONDARY	IGF-1 Levels.	4 years	ng/mL	MEDIAN
SECONDARY	Processing Speed Index 1 Year After Injury	1 year	Processing speed index standardized scor	MEDIAN
SECONDARY	GH Response to L-arginine Stimulation at Baseline	1 day	ng/mL	MEDIAN
SECONDARY	IGF-1 Levels	Baseline	Pearson's correlation coefficient	NUMBER
SECONDARY	Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.	4 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index	rhGH Treatment	82.5	Inter-Quartile Range 73.0 to 96.0	Processing speed index standardized scor
Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index	Placebo Treament	82.5	Inter-Quartile Range 79.0 to 99.0	Processing speed index standardized scor
IGF-1 Levels.	Active Treatment With Recombinant Human Growth Hormone	245.5	Inter-Quartile Range 203.5 to 321.5	ng/mL
IGF-1 Levels.	Placebo Treatment	173.0	Inter-Quartile Range 145.0 to 237.0	ng/mL
Processing Speed Index 1 Year After Injury	Active Treatment With Recombinant Human Growth Hormone	86.0	Inter-Quartile Range 76.0 to 111	Processing speed index standardized scor
Processing Speed Index 1 Year After Injury	Placebo Treatment	89.5	Inter-Quartile Range 81.0 to 99	Processing speed index standardized scor
GH Response to L-arginine Stimulation at Baseline	Active Treatment With Recombinant Human Growth Hormone	2.2	Inter-Quartile Range 0.6 to 5.9	ng/mL
GH Response to L-arginine Stimulation at Baseline	Placebo Treatment	1.2	Inter-Quartile Range 0.5 to 5.7	ng/mL
IGF-1 Levels	Active Treatment With Recombinant Human Growth Hormone	0.1		Pearson's correlation coefficient
IGF-1 Levels	Placebo Treatment	0.1		Pearson's correlation coefficient

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Treatment With Recombinant Human Growth Hormone	31
Overall Study	STARTED	Placebo Treatment	32
Overall Study	COMPLETED	Active Treatment With Recombinant Human Growth Hormone	16
Overall Study	COMPLETED	Placebo Treatment	18
Overall Study	NOT COMPLETED	Active Treatment With Recombinant Human Growth Hormone	15
Overall Study	NOT COMPLETED	Placebo Treatment	14

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arthralgia	Musculoskeletal and connective tissue disorders	Recombinant Human Growth Hormone	2	31	2
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo Treatment	6	32	6
other	Headache	Nervous system disorders	Recombinant Human Growth Hormone	1	31	31
other	Headache	Nervous system disorders	Placebo Treatment	3	32	32
other	Elective Surgery	General disorders	Recombinant Human Growth Hormone	6	31	31
other	Elective Surgery	General disorders	Placebo Treatment	4	32	32
other	Myalgia	Musculoskeletal and connective tissue disorders	Recombinant Human Growth Hormone	1	31	31
other	Myalgia	Musculoskeletal and connective tissue disorders	Placebo Treatment	6	32	32
other	Drowsiness	Nervous system disorders	Recombinant Human Growth Hormone	1	31	31
other	Drowsiness	Nervous system disorders	Placebo Treatment	1	32	32

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Recombinant Human Growth Hormone	0	31
Total, all-cause mortality	Placebo Treatment	0	32
Total, other adverse events	Recombinant Human Growth Hormone	12	31
Total, other adverse events	Placebo Treatment	15	32
Total, serious adverse events	Recombinant Human Growth Hormone	2	31
Total, serious adverse events	Placebo Treatment	2	32

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Recombinant Human Growth Hormone vs Placebo Treatment: deaths from any cause	Trial comparisons
Recombinant Human Growth Hormone vs Placebo Treatment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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