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Trial · Interventional

CompletedPhase 3Registry data

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

NCTNCT00499993 (opens ClinicalTrials.gov in a new tab)Other idA-93-52030-077
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
1 country

Italy

Start
Jan 2001
Primary completion
Not stated
Completion
May 2003
First posted
12 Jul 2007 (estimated)
Last update posted
15 Jan 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2001200220032004
  1. Ph 3

    Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

    NCT00499993

    Jan 2001 to May 2003

Registry summary

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

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Interventions

  • lanreotide (Autogel formulation), duration of treatment 46-48 weeksDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Growth hormone assessment

    Time frame · At every visit

Secondary outcomes(9)

  1. Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments

    Time frame · At every visit (with the exception of ALS at study inclusion)

  2. Prolactin (PRL) assessment

    Time frame · At study inclusion, visit 1 and at the final visit of the study

  3. Lanreotide assessment

    Time frame · At every visit

  4. Clinical symptoms

    Time frame · At every visit

  5. Quality of life

    Time frame · At visit 1 and at the final visit of the study

  6. Tumour size

    Time frame · At inclusion and at the final visit of the study

  7. Evaluation of carotid vessels (on an optional basis)

    Time frame · At inclusion and at the final visit of the study

  8. Safety assessment evaluated by clinical data

    Time frame · At every visit

  9. Safety assessment evaluated by laboratory data

    Time frame · At inclusion visit and at the final visit of the study

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 · 2009

22 results

Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly.

Lombardi et al. 2009Journal of endocrinological investigationcited by 36

PMID 19542735DOI 10.1007/bf03346453PUB-19542735

Rights unknown22 results
Source linkSee results (22)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values Exclusion Criteria: * Patients who have undergone pituitary surgery less than 3 months before selection * Patients previously treated with radiotherapy * Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

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