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

NCT00701363 | Completed Phase 4 Results

• 2 other identifiers: A-38-52030-2142007-005838-37
• Study Type: interventional
• Target: 124
• Locations: 13 countries
• Sites: 41

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

Outcome Measures

Primary Outcomes (1)

• 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)

  A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)

  At week 48 (End of Study)

Secondary Outcomes (14)

• Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)

  At week 24

• Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

  During phase 2 of the study (up to week 48)

• Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels

  At week 48

• Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval

  Baseline (visit 1) and week 48

• Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C

  Baseline (visit 1)

Study Arms (1)

Lanreotide Autogel 120 mg

EXPERIMENTAL

Drug: Lanreotide Autogel 120 mg

Interventions

Lanreotide Autogel 120 mg DRUG

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

Lanreotide Autogel 120 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (44)

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

Rio de Janeiro, Brazil

Location

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

São Paulo, Brazil

Location

Arhus University Hospital - Department of Medicinsk AVd M

Arhus C, DK 8000, Denmark

Location

Righospitalet - University Department of Endocrinology & Internal Medicine P

Copenhagen, DK-2100, Denmark

Location

Odense University Hospital - Department of Endocrinology

Odense C, DK-5000, Denmark

Location

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

Helsinki, 00290, Finland

Location

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

Kuopio, 70210, Finland

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Avicenne - Bâtiment Madeleine Breis

Bobigny, 93009, France

Location

Hôpital Neurologique - Pierre Wertheimer

Bron, 69677, France

Location

Hôpital du Bocage Sud - Service d'Endocrinologie

Dijon, 21079, France

Location

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

La Rochelle, 17019, France

Location

Hôpital Du Cluzeau - Service de Médecine B

Limoges, 87042, France

Location

Hôpital Archet 1 - Service d'Endocrinologie

Nice, 06200, France

Location

CHU de Nîmes - Hôpital Caremeau

Nîmes, 30029, France

Location

Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

Paris, 75010, France

Location

Hopital Pitié-Salpêtrière - Service d'Endocrinologie

Paris, 75013, France

Location

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

Paris, 75074, France

Location

Hôpital Haut Lévêque - Unité de soins normalisés

Pessac, 33604, France

Location

Hôpital Robert Debré

Reims, 51092, France

Location

Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

Strasbourg, 67098, France

Location

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

Tours, 37044, France

Location

Evangelismos Hospital - Department of Endocrinology

Athens, Greece

Location

Polykliniki Hospital - Department of Endocrinology

Athens, Greece

Location

Metaxa Hospital - Department of Endocrinology

Piraeus, Greece

Location

B IKA Panagia Hospital - Department of Endocrinology

Thessaloniki, Greece

Location

P. Stradins Clinical University Hospital - Department of Endocrinology

Riga, 1002, Latvia

Location

Erasmus Medical Centre - Department of Endocrinology

Rotterdam, NL-3015 CE, Netherlands

Location

UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

Utrecht, NL-3584 CX, Netherlands

Location

Department of Medicine, Haukeland Hospital Jonas Lies

Bergen, N-5009, Norway

Location

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

Kielce, 25-734, Poland

Location

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

Krakow, 31501, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

Wroclaw, 50-367, Poland

Location

University of Medicine and Pharmacy Iuliu Hatieganu

Cluj-Napoca, Romania

Location

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

Moscow, Russia

Location

I.M. Sechenov Moscow Medical Academy - Endocrinology Department

Moscow, Russia

Location

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

Belgrade, 11000, Serbia

Location

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

Novi Sad, 21000, Serbia

Location

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

Seoul, 110-744, South Korea

Location

Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

Seoul, 120-752, South Korea

Location

Sungkyunkwan University Samsung Medical Center

Seoul, 135-710, South Korea

Location

EM-Kliniken, Universitetssjukhuset

Linköping, 581 85, Sweden

Location

Skane University Hospital, Department of Endocrinology

Lund, 221 85, Sweden

Location

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

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Clinical Endocrinology and Metabolism
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 29, 2019
• Results First Posted: December 14, 2015

Record last verified: 2019-01

Locations

PL (3); BR (2); SE (2); FI (2); DK (3); GR (4); RO (1); FR (15); NL (2); LA (1); NO (1); RU (2); KR (3)