- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00630487
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)
26 februari 2013 uppdaterad av: Pfizer
Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study was terminated on 15-Dec-2008 due to poor recruitment.
Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin.
No safety reasons contributed to the termination.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Bad Aibling, Tyskland, 83043
- Pfizer Investigational Site
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Muenchen, Tyskland, 80804
- Pfizer Investigational Site
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Males and females between 18 and 65 years of age
- Isolated growth hormone deficiency
Exclusion Criteria:
- Isolated growth hormone deficiency by childhood onset
- Diabetes mellitus type 1 or 2
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo
|
Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase.
To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels.
Central lab will randomize placebo patients to dose change or maintenance of dose.
This will ensure continued blinding of the study to patients and personnel.
|
Aktiv komparator: Verum
|
Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg.
for the first 4 weeks half of the dose will be given.
After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range.
In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks).
At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
Tidsram: 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.
|
Baseline, 52 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Visceral Fat Mass in Subgroups
Tidsram: 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).
|
Baseline, 52 weeks, 78 weeks
|
Change From Baseline in Anthropometric Parameters (Height)
Tidsram: Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
Change From Baseline in Anthropometric Parameters (Weight)
Tidsram: Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
Change From Baseline in Anthropometric Parameters (Waist Circumference)
Tidsram: Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])
Tidsram: 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).
|
Baseline, Week 52, Week 78
|
Change From Baseline in Blood Pressure
Tidsram: 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.
|
Baseline, Week 52, Week 78
|
Change From Baseline in Heart Rate
Tidsram: 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.
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Baseline, Week 52, Week 78
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Change in Executive Function and Memory in Subgroups
Tidsram: 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.
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Baseline, Week 52, Week 78
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Change From Baseline in Safety Laboratory Assessments
Tidsram: Baseline, Week 52, Week 78
|
Prespecified safety laboratory assessments evaluated for change or no change from baseline.
Possible responses were Yes/No.
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Baseline, Week 52, Week 78
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Change From Baseline in Homeostasis Model Assessment (HOMA)-Index
Tidsram: Baseline, Week 52, Week 78
|
HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.
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Baseline, Week 52, Week 78
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Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)
Tidsram: Baseline, Week 52, Week 78
|
Participant self administered questionnaire consisting of 25 items that evoke yes or no answers.
A score of 1 is given to each item affirmed and these are summed to give the total score.
The maximum score is 25, which represents a poor quality of life.
The minimum score is 0, which represents a good quality of life.
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Baseline, Week 52, Week 78
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Change From Baseline in Short Form (36) Health Survey (SF36)
Tidsram: Baseline, Week 52, Week 78
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Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT).
Scale range 0 to 100, higher scores indicate a better health-related quality of life.
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Baseline, Week 52, Week 78
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)
Tidsram: Baseline, Week 52, Week 78
|
Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument.
The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression.
Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem).
The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled 'best imaginable health state' and 'worst imaginable health state'.
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Baseline, Week 52, Week 78
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Change From Baseline in Cardiovascular Risk Factors
Tidsram: Baseline, Week 52, Week 78
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Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)
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Baseline, Week 52, Week 78
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2008
Primärt slutförande (Faktisk)
1 oktober 2008
Avslutad studie (Faktisk)
1 oktober 2008
Studieregistreringsdatum
Först inskickad
28 februari 2008
Först inskickad som uppfyllde QC-kriterierna
28 februari 2008
Första postat (Uppskatta)
7 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 mars 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 februari 2013
Senast verifierad
1 februari 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A6281282
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