Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects

NCT ID: NCT00701363

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lanreotide Autogel 120 mg

Group Type: EXPERIMENTAL

Lanreotide Autogel 120 mg

Intervention Type: DRUG

120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24

Interventions

Lanreotide Autogel 120 mg

120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject has given written informed consent prior to any study-related procedures
• The subject is male or female and is over 18 years of age
• The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels
• The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
• If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period

Exclusion Criteria

• The subject has received radiation therapy to the pituitary gland before study entry
• The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
• The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry
• The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
• The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center

Rio de Janeiro, , Brazil

Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism

São Paulo, , Brazil

Arhus University Hospital - Department of Medicinsk AVd M

Arhus C, , Denmark

Righospitalet - University Department of Endocrinology & Internal Medicine P

Copenhagen, , Denmark

Odense University Hospital - Department of Endocrinology

Odense C, , Denmark

Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine

Helsinki, , Finland

Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division

Kuopio, , Finland

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

Hôpital Avicenne - Bâtiment Madeleine Breis

Bobigny, , France

Hôpital Neurologique - Pierre Wertheimer

Bron, , France

Hôpital du Bocage Sud - Service d'Endocrinologie

Dijon, , France

CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition

La Rochelle, , France

Hôpital Du Cluzeau - Service de Médecine B

Limoges, , France

Hôpital Archet 1 - Service d'Endocrinologie

Nice, , France

CHU de Nîmes - Hôpital Caremeau

Nîmes, , France

Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

Paris, , France

Hopital Pitié-Salpêtrière - Service d'Endocrinologie

Paris, , France

Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon

Paris, , France

Hôpital Haut Lévêque - Unité de soins normalisés

Pessac, , France

Hôpital Robert Debré

Reims, , France

Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

Strasbourg, , France

CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B

Tours, , France

Evangelismos Hospital - Department of Endocrinology

Athens, , Greece

Polykliniki Hospital - Department of Endocrinology

Athens, , Greece

Metaxa Hospital - Department of Endocrinology

Piraeus, , Greece

B IKA Panagia Hospital - Department of Endocrinology

Thessaloniki, , Greece

P. Stradins Clinical University Hospital - Department of Endocrinology

Riga, , Latvia

Erasmus Medical Centre - Department of Endocrinology

Rotterdam, , Netherlands

UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

Utrecht, , Netherlands

Department of Medicine, Haukeland Hospital Jonas Lies

Bergen, , Norway

Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine

Kielce, , Poland

University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17

Krakow, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

Wroclaw, , Poland

University of Medicine and Pharmacy Iuliu Hatieganu

Cluj-Napoca, , Romania

Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department

Moscow, , Russia

I.M. Sechenov Moscow Medical Academy - Endocrinology Department

Moscow, , Russia

Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13

Belgrade, , Serbia

Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9

Novi Sad, , Serbia

Seoul National University hospital, 28 Yongon-dong Chongno-gu

Seoul, , South Korea

Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

Seoul, , South Korea

Sungkyunkwan University Samsung Medical Center

Seoul, , South Korea

EM-Kliniken, Universitetssjukhuset

Linköping, , Sweden

Skane University Hospital, Department of Endocrinology

Lund, , Sweden

Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna

Stockholm, , Sweden

Countries

Brazil; Denmark; Finland; France; Greece; Latvia; Netherlands; Norway; Poland; Romania; Russia; Serbia; South Korea; Sweden

Other Identifiers

2007-005838-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A-38-52030-214

Identifier Type: -

Identifier Source: org_study_id