Preoperative Octreotide Treatment of Acromegaly

Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00521300

Acronym

POTA

Enrollment

Registered

2007-08-27

Start date

1999-09-30

Completion date

2010-05-31

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly

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.

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.

Interventions

DRUGOctreotide

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

PROCEDUREDirect surgery for acromegaly

Direct transsphenoidal surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Surgical cure by transsphenoidal surgery	Primarily 3 months postoperatively, but up to 10 years postoperatively

Secondary

Measure	Time frame
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	Primarily 3 months postoperatively, but up to 10 years postoperatively

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026