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NCT00210457·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

63

Locations

17

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Lanreotide (Autogel formulation)

Timeline

From registration to results.

  1. First posted

    Sep 21, 2005

  2. Study start

    Sep 2000

  3. Primary completion

    Jul 15, 2002

  4. Study completion

    Jul 15, 2002

  5. Results posted

    Not reported

  6. Registry updated

    Mar 31, 2020

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

17 registered sites.

France · Switzerland. Showing up to 24 locations stored in the fast local snapshot.

Hôpital Sud

Amiens, France

Chu d'Angers

Angers, France

Hôpital de Bois Guillaume

Bois-Guillaume, France

Chu de la Cote de Nacre

Caen, France

Hôpital du Bocage

Dijon, France

Chu de Bicêtre

Le Kremlin-Bicêtre, France

Hôpital du Cluzeau

Limoges, France

Hôpital Neurologique

Lyon, France

Hôpital Lapeyronie

Montpellier, France

Hôpital de l'Archet 1

Nice, France

Hôpital du Haut-Levêque

Pessac, France

Hôpital Maison Blanche

Reims, France

Hôpital Sud

Rennes, France

Hôpital Bellevue

Saint-Etienne, France

Hôpital de Hautepierre

Strasbourg, France

Hôpital de Rangueil

Toulouse, France

Centre Hospitalier Vaudois

Lausanne, Switzerland

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

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