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Trial · Interventional

CompletedPhase 4Registry data

Preoperative Octreotide Treatment of Acromegaly

Short name POTA

NCTNCT00521300 (opens ClinicalTrials.gov in a new tab)Other idS-71-98 (REK)Other idS-71-98Other idSLKNR 98-5560
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
62 participants (actual)
Sponsor
St. Olavs Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Norway

Start
Sept 1999
Primary completion
Jun 2005
Completion
May 2010
First posted
27 Aug 2007 (estimated)
Last update posted
2 Jun 2014 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200020022004200620082010
  1. Ph 4

    POTA

    NCT00521300

    Sept 1999 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OctreotideDrug
  • Direct surgery for acromegalyProcedure

Arms2

  • Experimental

    octreotide

    6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

  • Active comparator

    standard surgery

    Standard transphenoidal surgery soon after the diagnosis of acromegaly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Surgical cure by transsphenoidal surgery

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

Secondary outcomes(1)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

3 results

Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial.

Fougner et al. 2014European journal of endocrinologycited by 49

PMID 24866574DOI 10.1530/eje-14-0249PUB-24866574

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2008

3 results

Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial.

Carlsen et al. 2008The Journal of clinical endocrinology and metabolismcited by 132

PMID 18492760DOI 10.1210/jc.2008-0315PUB-18492760

Rights unknown3 results
Source linkSee results (3)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

Inflammatory adipokines contribute to insulin resistance in active acromegaly and respond differently to different treatment modalities.

Olarescu et al. 2014European journal of endocrinologycited by 25

PMID 24092547DOI 10.1530/eje-13-0523PUB-24092547

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2011

Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure.

Carlsen et al. 2011Clinical endocrinologycited by 34

PMID 21521254DOI 10.1111/j.1365-2265.2011.03982.xPUB-21521254

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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