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Preoperative Octreotide Treatment of Acromegaly (POTA)

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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

Study Description

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.

Study Design

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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

Drug Information available for: Octreotide acetate Octreotide

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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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.

Contacts and Locations

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

More Information

Publications of Results:

Carlsen SM, Lund-Johansen M, Schreiner T, Aanderud S, Johannesen O, Svartberg J, Cooper JG, Hald JK, Fougner SL, Bollerslev J; Preoperative Octreotide Treatment of Acromegaly study group. Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab. 2008 Aug;93(8):2984-90. doi: 10.1210/jc.2008-0315. Epub 2008 May 20.

Carlsen SM, Svartberg J, Schreiner T, Aanderud S, Johannesen O, Skeie S, Lund-Johansen M, Fougner SL, Bollerslev J; POTA study group. Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure. Clin Endocrinol (Oxf). 2011 Jun;74(6):736-43. doi: 10.1111/j.1365-2265.2011.03982.x.

Fougner SL, Bollerslev J, Svartberg J, Øksnes M, Cooper J, Carlsen SM. Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial. Eur J Endocrinol. 2014 Aug;171(2):229-35. doi: 10.1530/EJE-14-0249. Epub 2014 May 27.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Olarescu NC, Ueland T, Godang K, Lindberg-Larsen R, Jørgensen JO, Bollerslev J. Inflammatory adipokines contribute to insulin resistance in active acromegaly and respond differently to different treatment modalities. Eur J Endocrinol. 2013 Nov 22;170(1):39-48. doi: 10.1530/EJE-13-0523. Print 2014 Jan.

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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

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