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Trial · Interventional

CompletedPhase 4Registry data

Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

NCTNCT00145405 (opens ClinicalTrials.gov in a new tab)Other id009
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Overview

Status
Completed
Phase
Phase 4
Enrollment
12 participants
Sponsor
Odense University Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Denmark

Start
Sept 2002
Primary completion
Not stated
Completion
Dec 2004
First posted
5 Sept 2005 (estimated)
Last update posted
8 Sept 2006 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200320042005
  1. Ph 4

    Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

    NCT00145405

    Sept 2002 to Dec 2004

Registry summary

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

The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important. Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed. Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days. Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.

Interventions

  • Lanreotide Autogel and Octreotide LARDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. GH and IGF-I levels after 4, 6, 10, 12 months therapy.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 22 Years up to 72 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * All the patients which receive octreotide LAR can be included; * New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated; * As long as they do not fit in the exclusion criteria. Exclusion Criteria: * Which had not given their consent after they received standard information about the study; * Current malign disease; * Somatostatin analogues intolerance; * Elevation of lever enzymes; * Pregnancy.

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