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

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: June 18, 2008
Last updated: October 7, 2013
Last verified: October 2013
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

Condition Intervention Phase
Drug: Lanreotide Autogel 120 mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of subjects having maintained their injection interval schedule of six weeks or increased their injection interval to eight weeks whilst keeping their normalised insulin growth factor (IGF 1) levels (age and sex adjusted) [ Time Frame: At study end at Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with normalised IGF 1 levels (age and sex adjusted) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects having maintained an injection interval of six weeks or increasing their injection interval to eight weeks [ Time Frame: During Phase 2 of the study ] [ Designated as safety issue: No ]
  • Mean change from baseline in IGF 1 values (expressed as % of upper limit of normal (ULN)) overall and by injection interval [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Maintain normalised IGF 1 values [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Symptoms of acromegaly (headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia) [ Time Frame: At baseline, Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Mean changes from baseline in Quality of Life scores (AcroQoL* and SF 36) [ Time Frame: At Week 24 and Week 48 ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: October 2008
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanreotide Autogel 120 mg Drug: Lanreotide Autogel 120 mg
120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00701363

  Hide Study 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
Sao Paulo, Brazil
Arhus University Hospital - Department of Medicinsk AVd M
Arhus C, Denmark, DK 8000
Righospitalet - University Department of Endocrinology & Internal Medicine P
Copenhagen, Denmark, DK-2100
Odense University Hospital - Department of Endocrinology
Odense C, Denmark, DK-5000
Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine
Helsinki, Finland, 00290
Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division
Kuopio, Finland, 70210
CHU Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Hôpital Avicenne - Bâtiment Madeleine Breis
Bobigny, France, 93009
Hôpital Neurologique - Pierre Wertheimer
Bron, France, 69677
Hôpital du Bocage Sud - Service d'Endocrinologie
Dijon, France, 21079
CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition
La Rochelle, France, 17019
Hôpital Du Cluzeau - Service de Médecine B
Limoges, France, 87042
Hôpital Archet 1 - Service d'Endocrinologie
Nice, France, 06200
CHU de Nîmes - Hôpital Caremeau
Nîmes, France, 30029
Hopital Pitié-Salpêtrière - Service d'Endocrinologie
Paris, France, 75013
Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon
Paris, France, 75074
Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition
Paris, France, 75010
Hôpital Haut Lévêque - Unité de soins normalisés
Pessac, France, 33604
Hôpital Robert Debré
Reims, France, 51092
Hôpital de Hautepierre, Service de Médecine Interne et Nutrition
Strasbourg, France, 67098
CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B
Tours, France, 37044
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
Korea, Republic of
Seoul National University hospital, 28 Yongon-dong Chongno-gu
Seoul, Korea, Republic of, 110-744
Sungkyunkwan University Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Yonsei University Severance Hospital - Department of Endocrinology and Metabolism
Seoul, Korea, Republic of, 120-752
P. Stradins Clinical University Hospital - Department of Endocrinology
Riga, Latvia, 1002
Erasmus Medical Centre - Department of Endocrinology
Rotterdam, Netherlands, NL-3015 CE
UMC Utrecht - Department of Endocrinology, Heidelberglaan 100
Utrecht, Netherlands, NL-3584 CX
Department of Medicine, Haukeland Hospital Jonas Lies
Bergen, Norway, N-5009
Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine
Kielce, Poland, 25-734
University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17
Krakow, Poland, 31501
Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4
Wroclaw, Poland, 50-367
University of Medicine and Pharmacy Iuliu Hatieganu
Cluj-Napoca, Romania
Russian Federation
I.M. Sechenov Moscow Medical Academy - Endocrinology Department
Moscow, Russian Federation
Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department
Moscow, Russian Federation
Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13
Belgrade, Serbia, 11000
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9
Novi Sad, Serbia, 21000
EM-Kliniken, Universitetssjukhuset
Linkoping, Sweden, 581 85
Skane University Hospital, Department of Endocrinology
Lund, Sweden, 221 85
Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna
Stockholm, Sweden, 17176
Sponsors and Collaborators
Study Director: Xuan Mai TRUONG THANH, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen Identifier: NCT00701363     History of Changes
Other Study ID Numbers: A-38-52030-214, 2007-005838-37
Study First Received: June 18, 2008
Last Updated: October 7, 2013
Health Authority: Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Latvia: State Agency of Medicines
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ministry of Health of the Russian Federation
Greece: National Organization of Medicines
Brazil: Ministry of Health
Norway: Norwegian Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Ministry of Health
Romania: Ministry of Public Health

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015