Preoperative Octreotide Treatment of Acromegaly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acromegaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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octreotide

6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

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

standard surgery

Standard transphenoidal surgery soon after the diagnosis of acromegaly

Group Type ACTIVE_COMPARATOR

Direct surgery for acromegaly

Intervention Type PROCEDURE

Direct transsphenoidal surgery

Interventions

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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

Intervention Type DRUG

Direct surgery for acromegaly

Direct transsphenoidal surgery

Intervention Type PROCEDURE

Other Intervention Names

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Sandostatin Sandostatin LAR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No