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Trial · Interventional

CompletedPhase 4Registry data

Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

NCTNCT00216398 (opens ClinicalTrials.gov in a new tab)Other idA-9B-52030-159
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
8 participants (actual)
Sponsor
Ipsen · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Australia

Start
Jun 2004
Primary completion
22 Jun 2006
Completion
22 Jun 2006
First posted
22 Sept 2005 (estimated)
Last update posted
16 Aug 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200520062007
  1. Ph 4

    Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

    NCT00216398

    Jun 2004 to 22 Jun 2006

Registry summary

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

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Interventions

  • Lanreotide (Autogel formulation)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary outcomes(8)

  1. The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.

  2. The percentage of patients with normalised IGF-1 compared to the baseline visit.

  3. Change in the GH values compared to the baseline (Week 0) visit.

  4. Change in the IGF-1 values compared to the baseline (Week 0) visit.

  5. Change in serum lanreotide levels compared to the baseline (Week 0) visit.

  6. Change in the serum octreotide levels compared to the baseline visit.

  7. Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

  8. Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

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 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of acromegaly * The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L. * The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry * Life expectancy of at least 2 years Exclusion Criteria: * Adenectomy within past 6 months, or likely during study period * Radiotherapy for acromegalic disease within 1 year, or likely during study period * Unstable concomitant dopamine agonist therapy

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