Preoperative Octreotide Treatment of Acromegaly - Full Text View

Sponsors and Collaborators:	St. Olavs Hospital Novartis
Information provided by:	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00521300

Purpose

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
Acromegaly	Drug: Octreotide Procedure: Direct surgery for acromegaly Drug: Preoperative octreotide treatment before transsphenoidal surgery for acromegaly	Phase IV

Drug Information available for: Octreotide Octreotide acetate Somatotropin Somatropin

U.S. FDA Resources

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

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:

Surgical cure by transsphenoidal surgery [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ]

Secondary Outcome Measures:

Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ]

Enrollment:	62
Study Start Date:	September 1999
Estimated Study Completion Date:	May 2015

Arms	Assigned Interventions
1: Active Comparator Direct surgery for acromegaly	Procedure: Direct surgery for acromegaly
2: Experimental Preoperative octreotide treatment	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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
Pituitary tumor by MRI-scan.

Exclusion Criteria:

Immediate surgery indicated by usual clinical criteria.
Pregnant.
Known adverse effects of octreotide.
Unfit for participation by any other reason.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521300

Locations

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

Sponsors and Collaborators

St. Olavs Hospital

Novartis

Investigators

Principal Investigator:

Sven M Carlsen, MD, PhD

Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway

More Information

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

Keywords provided by St. Olavs Hospital:

Acromegaly

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Hyperpituitarism
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009