NCT00210457

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2000

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

September 19, 2005

Last Update Submit

March 30, 2020

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (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)

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

  • Mean growth hormone (GH) levels

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

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

  • Number of patients with no or reduced clinical signs of acromegaly

  • +1 more secondary outcomes

Interventions

Lanreotide (Autogel formulation)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hôpital Sud

Amiens, 80054, France

Location

Chu d'Angers

Angers, 49033, France

Location

Hôpital de Bois Guillaume

Bois-Guillaume, 76233, France

Location

Chu de la Cote de Nacre

Caen, 14033, France

Location

Hôpital du Bocage

Dijon, 21034, France

Location

Chu de Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital du Cluzeau

Limoges, 87042, France

Location

Hôpital Neurologique

Lyon, 69394, France

Location

Hôpital Lapeyronie

Montpellier, 34059, France

Location

Hôpital de l'Archet 1

Nice, 06202, France

Location

Hôpital du Haut-Levêque

Pessac, 33604, France

Location

Hôpital Maison Blanche

Reims, 51092, France

Location

Hôpital Sud

Rennes, 35056, France

Location

Hôpital Bellevue

Saint-Etienne, 42055, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Hôpital de Rangueil

Toulouse, 31403, France

Location

Centre Hospitalier Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (1)

  • Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.

    PMID: 18248639RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 21, 2005

Study Start

September 1, 2000

Primary Completion

July 15, 2002

Study Completion

July 15, 2002

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

CH(1)FR(16)