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Sponsors and Collaborators: |
St. Olavs Hospital Novartis |
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Information provided by: | St. Olavs Hospital |
ClinicalTrials.gov Identifier: | NCT00521300 |
The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.
Condition | Intervention | Phase |
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Acromegaly |
Drug: Octreotide Procedure: Direct surgery for acromegaly Drug: Preoperative octreotide treatment before transsphenoidal surgery for acromegaly |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas |
Enrollment: | 62 |
Study Start Date: | September 1999 |
Estimated Study Completion Date: | May 2015 |
Arms | Assigned Interventions |
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1: Active Comparator
Direct surgery for acromegaly
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Procedure: Direct surgery for acromegaly |
2: Experimental
Preoperative octreotide treatment
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Drug: Octreotide
First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months
Drug: Preoperative octreotide treatment before transsphenoidal surgery for acromegaly
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Endocrinology, St. Olavs Hospital | |
Trondheim, Norway, 7006 | |
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center | |
Oslo, Norway | |
Endocrinology Unit, Department of Medicine, Aker University Hospital | |
Oslo, Norway | |
Endocrinology Unit, Department of Medicine, Haukeland University Hospital | |
Bergen, Norway | |
Endocrinology Unit, Department of Medicine, University Hospital of North Norway | |
Tromsø, Norway |
Principal Investigator: | Sven M Carlsen, MD, PhD | Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway |
Study ID Numbers: | S-71-98 (REK), S-71-98 (REK), SLKNR 98-5560 (SLK) |
Study First Received: | August 24, 2007 |
Last Updated: | August 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00521300 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services |
Acromegaly |
Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Octreotide Central Nervous System Diseases Endocrine System Diseases Pituitary Neoplasms Brain Diseases |
Bone Diseases Growth Hormone-Secreting Pituitary Adenoma Musculoskeletal Diseases Endocrinopathy Adenoma Endocrine Gland Neoplasms Acromegaly Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Hyperpituitarism Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Nervous System Diseases Gastrointestinal Agents Pharmacologic Actions |