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Trial · Interventional

CompletedPhase 2/3Registry data

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

NCTNCT00234572 (opens ClinicalTrials.gov in a new tab)Other idE-28-52030-717
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
108 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Double masking
Countries
8 countries

United States, Czechia, France, Germany, Hong Kong, Hungary, Netherlands, United Kingdom

Start
May 2000
Primary completion
3 Jan 2003
Completion
3 Jan 2003
First posted
7 Oct 2005 (estimated)
Last update posted
2 Aug 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20002001200220032004
  1. Ph 2/3

    Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

    NCT00234572

    May 2000 to 3 Jan 2003

Registry summary

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

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Interventions

  • Lanreotide (Autogel formulation)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

Secondary outcomes(1)

  1. Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

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: Randomized controlled trial · 2010

11 results

Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.

Melmed et al. 2010Pituitarycited by 86

PMID 19639415PMC2807598DOI 10.1007/s11102-009-0191-1PUB-19639415

Free to read · publisher termsCC BY-NC11 results
Read at sourceSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * documentation of a diagnosis of active acromegaly based on either of the following definitions: 1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level \>5ng/mL at visit 1; or 2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH \>3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a) Exclusion Criteria: * receipt of radiotherapy for acromegaly within 3 years * pituitary surgery within 3 months prior to visit 1 * prior receipt of lanreotide autogel or GH antagonist * anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period * known hypersensitivity to any of the test materials or related compounds * clinically significant renal or hepatic abnormalities

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