Preoperative Octreotide Treatment of Acromegaly (POTA)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00521300
First received: August 24, 2007
Last updated: October 20, 2011
Last verified: October 2011
  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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 1999
Study Completion Date: May 2010
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: octreotide
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
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
Other Names:
  • Sandostatin
  • Sandostatin LAR
Active Comparator: standard surgery
Standard transphenoidal surgery soon after the diagnosis of acromegaly
Procedure: Direct surgery for acromegaly
Direct transsphenoidal surgery

Detailed Description:

After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide.

To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.

  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
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
Bergen, Norway
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, University Hospital of North Norway
Tromsø, Norway
Department of Endocrinology, St. Olavs Hospital
Trondheim, Norway, 7006
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00521300     History of Changes
Obsolete Identifiers: NCT00241033
Other Study ID Numbers: S-71-98 (REK), S-71-98, SLKNR 98-5560
Study First Received: August 24, 2007
Last Updated: October 20, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
Acromegaly

Additional relevant MeSH terms:
Acromegaly
Growth Hormone-Secreting Pituitary Adenoma
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014