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Trial record 4 of 17 for:    "Adenoma" | "Octreotide"

Preoperative Octreotide Treatment of Acromegaly (POTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00521300
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Acromegaly Drug: Octreotide Procedure: Direct surgery for acromegaly Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
Study Start Date : September 1999
Actual Primary Completion Date : June 2005
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521300


Locations
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Norway
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
Bergen, Norway
Endocrinology Unit, Department of Medicine, Aker University Hospital
Oslo, Norway
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
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
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Principal Investigator: Sven M Carlsen, MD, PhD Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 ( Other Identifier: REK )
SLKNR 98-5560 ( Other Identifier: SLK )
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by St. Olavs Hospital:
Acromegaly
Additional relevant MeSH terms:
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Octreotide
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents