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Trial · Interventional

CompletedPhase 3Registry data

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

NCTNCT00210457 (opens ClinicalTrials.gov in a new tab)Other idE-54-52030-081
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
63 participants (actual)
Sponsor
Ipsen · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

France, Switzerland

Start
Sept 2000
Primary completion
15 Jul 2002
Completion
15 Jul 2002
First posted
21 Sept 2005 (estimated)
Last update posted
31 Mar 2020
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2000200120022003
  1. Ph 3

    Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

    NCT00210457

    Sept 2000 to 15 Jul 2002

Registry summary

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

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

Interventions

  • Lanreotide (Autogel formulation)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

Secondary outcomes(6)

  1. Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range

  2. Mean growth hormone (GH) levels

  3. Number of patients having a serum GH level at or below 2.5ng/ml

  4. Number of patients having a serum GH level at or below 1 ng/ml

  5. Number of patients with no or reduced clinical signs of acromegaly

  6. Long-term safety of repeated injections of lanreotide autogel at titrated doses

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2008

7 results

Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly.

Chanson et al. 2008Clinical endocrinologycited by 53

PMID 18248639PMC2610402DOI 10.1111/j.1365-2265.2008.03208.xPUB-18248639

CC BY7 results
Download PDFSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions: * patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range, * patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range. Exclusion Criteria: * Patient having had pituitary surgery within the previous 3 months * Patient having received radiotherapy for acromegaly disease within the previous 36 months * Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period * Patient having received lanreotide autogel at any time before the study

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