Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145405
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2005-09-02
Brief Title:
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH IGF-I Levels and Patient Satisfaction
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The morbidity and the mortality in acromegalic patients closely correspond to growth hormone GH levels and therefore efficient long-term treatment is important
Neurosurgery is the first choice of treatment in acromegalic patients Surgery normalizes GH levels in about 80 of patients with microadenomas but less than 50 of patients with macroadenomas respond sufficiently to surgery alone In most patients additional medical therapy is therefore needed
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels Lanreotide Autogel LAN is a new formulation of lanreotide consisting of a prolonged release aqueous formulation which can be injected intramuscularly or deep subcutaneously once every 28 days
Aim
The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus Furthermore we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction
Neurosurgery is the first choice of treatment in acromegalic patients Surgery normalizes GH levels in about 80 of patients with microadenomas but less than 50 of patients with macroadenomas respond sufficiently to surgery alone In most patients additional medical therapy is therefore needed
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels Lanreotide Autogel LAN is a new formulation of lanreotide consisting of a prolonged release aqueous formulation which can be injected intramuscularly or deep subcutaneously once every 28 days
Aim
The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus Furthermore we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction
Detailed Description:
Introduction The morbidity and the mortality in acromegalic patients closely correspond to growth hormone GH levels and therefore efficient long-term treatment is important 1
Neurosurgery is the first choice of treatment in acromegalic patients Surgery normalizes GH levels in about 80 of patients with microadenomas but less than 50 of patients with macroadenomas respond sufficiently to surgery alone 1 In most patients additional medical therapy is therefore needed
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels 2 3 4 5 Lanreotide Autogel LAN is a new formulation of lanreotide consisting of a prolonged release aqueous formulation which can be injected intramuscularly or deep subcutaneously once every 28 days
Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus Furthermore we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction
Inclusion criteria
all the patients which receive octreotide LAR can be included
new diagnosed patients with clinical and biochemical acromegaly if medicine therapy is indicated
as long as they do not fit in the exclusion criteria Exclusion criteria
which had not given their consent after they received standard information about the study
current malign disease
somatostatin analogues intolerance
elevation of lever enzymes
pregnancy
Design The study is designed as a randomized cross-over trial Patients will be randomized to receive either OCT or LAN for 6 months and will be then changed to the opposite therapy for 6 months without interruption between the two therapies Both OCT and LAN will be administered once every 28 days OCT will be given intramuscularly and LAN deep subcutaneously by the patients general practitioner or by a study nurse At times 0 4 6 10 and 12 months the patients will be attended for clinical evaluation at the department of Endocrinology Odense University Hospital
Patients previously treated with OCT will receive unchanged doses of OCT during the study period and OCT dose will use to calculate LAN doses The administered OCT dose will be determined as the dose necessary to obtain normal IGF-I levels andor GH1mUl 04 μg l or alternatively the highest tolerated dose
The LAN doses will be calculated using the OCT doses as follows 10 mg OCT 60 mg LAN 20 mg OCT 90 mg LAN 30 mg OCT 120 mg LAN
Evaluation program at 0 4 6 10 12 months Clinical evaluation weight blood pressure inspection of the injection site and evaluation of possible side effects
Analyses GH and IGF-I prolactin thyroid hormone oestrogen testosterone LH and FSH fasting plasma glucose and glycosylated hemoglobin liver enzymes levels
The study will be supported by Beaufor Ipsen Industry and further technical assistance will be supplied by Endocrinology Department Odense University Hospital
References
1 Giustina A Barkan A Casanueva F F Cavagnini F Frohman L Ho K Veldhuis J Wass J Von Werder K and Melmed S Criteria for cure of acromegaly a consensus statementJClinEndocrinolMetab 2000 85 526-529
2 Chanson P Somatostatin analogs in the treatment of acromegaly the choice is now possibleEurJEndocrinol 2000 143 573-575
3 Cozzi R Dallabonzana D Attanasio R Barausse M and Oppizzi G A comparison between octreotide-LAR and lanreotide-SR in the chronic treatment of acromegalyEurJEndocrinol 1999 141 267-271
4 Turner H E Vadivale A Keenan J and Wass J A A comparison of lanreotide and octreotide LAR for treatment of acromegalyClinEndocrinolOxf 1999 51 275-280
5 Verhelst J A Pedroncelli A M Abs R Montini M Vandeweghe M V Albani G Maiter D Pagani M D Legros J J Gianola D Bex M Poppe K Mockel J and Pagani G Slow-release lanreotide in the treatment of acromegaly a study in 66 patientsEurJEndocrinol 2000 143 577-584
Neurosurgery is the first choice of treatment in acromegalic patients Surgery normalizes GH levels in about 80 of patients with microadenomas but less than 50 of patients with macroadenomas respond sufficiently to surgery alone 1 In most patients additional medical therapy is therefore needed
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels 2 3 4 5 Lanreotide Autogel LAN is a new formulation of lanreotide consisting of a prolonged release aqueous formulation which can be injected intramuscularly or deep subcutaneously once every 28 days
Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus Furthermore we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction
Inclusion criteria
all the patients which receive octreotide LAR can be included
new diagnosed patients with clinical and biochemical acromegaly if medicine therapy is indicated
as long as they do not fit in the exclusion criteria Exclusion criteria
which had not given their consent after they received standard information about the study
current malign disease
somatostatin analogues intolerance
elevation of lever enzymes
pregnancy
Design The study is designed as a randomized cross-over trial Patients will be randomized to receive either OCT or LAN for 6 months and will be then changed to the opposite therapy for 6 months without interruption between the two therapies Both OCT and LAN will be administered once every 28 days OCT will be given intramuscularly and LAN deep subcutaneously by the patients general practitioner or by a study nurse At times 0 4 6 10 and 12 months the patients will be attended for clinical evaluation at the department of Endocrinology Odense University Hospital
Patients previously treated with OCT will receive unchanged doses of OCT during the study period and OCT dose will use to calculate LAN doses The administered OCT dose will be determined as the dose necessary to obtain normal IGF-I levels andor GH1mUl 04 μg l or alternatively the highest tolerated dose
The LAN doses will be calculated using the OCT doses as follows 10 mg OCT 60 mg LAN 20 mg OCT 90 mg LAN 30 mg OCT 120 mg LAN
Evaluation program at 0 4 6 10 12 months Clinical evaluation weight blood pressure inspection of the injection site and evaluation of possible side effects
Analyses GH and IGF-I prolactin thyroid hormone oestrogen testosterone LH and FSH fasting plasma glucose and glycosylated hemoglobin liver enzymes levels
The study will be supported by Beaufor Ipsen Industry and further technical assistance will be supplied by Endocrinology Department Odense University Hospital
References
1 Giustina A Barkan A Casanueva F F Cavagnini F Frohman L Ho K Veldhuis J Wass J Von Werder K and Melmed S Criteria for cure of acromegaly a consensus statementJClinEndocrinolMetab 2000 85 526-529
2 Chanson P Somatostatin analogs in the treatment of acromegaly the choice is now possibleEurJEndocrinol 2000 143 573-575
3 Cozzi R Dallabonzana D Attanasio R Barausse M and Oppizzi G A comparison between octreotide-LAR and lanreotide-SR in the chronic treatment of acromegalyEurJEndocrinol 1999 141 267-271
4 Turner H E Vadivale A Keenan J and Wass J A A comparison of lanreotide and octreotide LAR for treatment of acromegalyClinEndocrinolOxf 1999 51 275-280
5 Verhelst J A Pedroncelli A M Abs R Montini M Vandeweghe M V Albani G Maiter D Pagani M D Legros J J Gianola D Bex M Poppe K Mockel J and Pagani G Slow-release lanreotide in the treatment of acromegaly a study in 66 patientsEurJEndocrinol 2000 143 577-584
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None