Acromegaly Clinical Trial
— SAPOROOfficial title:
Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma
The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.
Status | Completed |
Enrollment | 89 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - men and women - 18-80 years old - untreated acromegaly - unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels - presence of a pituitary adenoma on MRI - informed consent given. Exclusion Criteria: - acromegaly previously treated - contraindication to pituitary surgery - associated hyperprolactinemia above 200 ng/ml - visual field defect needing rapid transsphenoidal surgery - contraindication to a treatment with octreotide |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers | |
France | Besançon University Hospital | Besançon | |
France | Caen University Hospital | Caen | |
France | Grenoble University Hospital | Grenoble | |
France | Paris XI University Hospital | Le Kremlin Bicetre | |
France | Lille University Hospital | Lille | |
France | University Hospital of Limoges | Limoges | |
France | Lyon University Hospital | Lyon | |
France | Marseille University Hospital | Marseille | |
France | Bordeaux University Hospital | Pessac | |
France | Rouen University Hospital | Rouen | |
France | Strasbourg University Hospital | Strasbourg | |
France | Toulouse Universtiy Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IGF1 plasma levels | 3 months and 12 months after transphenoidal surgery | No | |
Secondary | GH plasma levels | 3 and 12 months after transphenoidal surgery | No | |
Secondary | Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters. | at transphenoidal surgery | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06344650 -
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
|
||
Active, not recruiting |
NCT02092129 -
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.
|
N/A | |
Completed |
NCT02012127 -
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
|
||
Active, not recruiting |
NCT01265121 -
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
|
N/A | |
Terminated |
NCT00765323 -
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
|
Phase 3 | |
Completed |
NCT00531908 -
Physiopathology of Sodium Retention in Acromegaly
|
N/A | |
Completed |
NCT00500227 -
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
|
||
Completed |
NCT01278342 -
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
|
Phase 4 | |
Active, not recruiting |
NCT01809808 -
A Prospective Study of Outcome After Therapy for Acromegaly
|
||
Completed |
NCT00145405 -
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
|
Phase 4 | |
Completed |
NCT00210457 -
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
|
Phase 3 | |
Recruiting |
NCT05401084 -
Diet in the Management of Acromegaly
|
N/A | |
Recruiting |
NCT00005100 -
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
|
N/A | |
Completed |
NCT00521300 -
Preoperative Octreotide Treatment of Acromegaly
|
Phase 4 | |
Completed |
NCT03548415 -
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
|
Phase 2 | |
Not yet recruiting |
NCT04066569 -
Reproducibility and Utility of OGTT in Acromegaly
|
N/A | |
Not yet recruiting |
NCT05298891 -
Hypoproteic Diet in Acromegaly
|
N/A | |
Recruiting |
NCT04520646 -
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
|
N/A | |
Not yet recruiting |
NCT04529356 -
The TMS Treatment for Postoperative Headache in GH Tumor
|
N/A | |
Active, not recruiting |
NCT03252353 -
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
|
Phase 3 |