Clinical trial NCT00701363: Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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)
timeFrame: At week 48 (End of Study)
Secondary outcomes:
measure: Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
timeFrame: At week 24
measure: Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks
timeFrame: During phase 2 of the study (up to week 48)
measure: Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels
timeFrame: At week 48
measure: Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval
timeFrame: Baseline (visit 1) and week 48
measure: 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
timeFrame: Baseline (visit 1)
measure: Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24
timeFrame: Baseline (visit 1)
measure: Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
timeFrame: At baseline, week 24 and week 48
measure: Mean Changes From Baseline in Quality of Life Scores (AcroQoL)
timeFrame: At weeks 24 and 48
measure: Mean Changes From Baseline in Quality of Life Scores (SF-36)
timeFrame: At weeks 24 and 48
measure: Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48
timeFrame: At week 48 (End of Study)
measure: Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit
timeFrame: At weeks 24 and 48
measure: Serum Growth Hormone (GH) Levels
timeFrame: At Baseline, week 24 and week 48
measure: Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
timeFrame: At weeks 24 and 48
measure: Subject Treatment Schedule Preference
timeFrame: At weeks 24 and 48
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism
city: Arhus C
country: Denmark
facility: Arhus University Hospital - Department of Medicinsk AVd M
city: Copenhagen
country: Denmark
facility: Righospitalet - University Department of Endocrinology & Internal Medicine P
city: Odense C
country: Denmark
facility: Odense University Hospital - Department of Endocrinology
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine
city: Kuopio
country: Finland
facility: Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bobigny
country: France
facility: Hôpital Avicenne - Bâtiment Madeleine Breis
city: Bron
country: France
facility: Hôpital Neurologique - Pierre Wertheimer
city: Dijon
country: France
facility: Hôpital du Bocage Sud - Service d'Endocrinologie
city: La Rochelle
country: France
facility: CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition
city: Limoges
country: France
facility: Hôpital Du Cluzeau - Service de Médecine B
city: Nice
country: France
facility: Hôpital Archet 1 - Service d'Endocrinologie
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Caremeau
city: Paris
country: France
facility: Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition
city: Paris
country: France
facility: Hopital Pitié-Salpêtrière - Service d'Endocrinologie
city: Paris
country: France
facility: Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon
city: Pessac
country: France
facility: Hôpital Haut Lévêque - Unité de soins normalisés
city: Reims
country: France
facility: Hôpital Robert Debré
city: Strasbourg
country: France
facility: Hôpital de Hautepierre, Service de Médecine Interne et Nutrition
city: Tours
country: France
facility: CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B
city: Athens
country: Greece
facility: Evangelismos Hospital - Department of Endocrinology
city: Athens
country: Greece
facility: Polykliniki Hospital - Department of Endocrinology
city: Piraeus
country: Greece
facility: Metaxa Hospital - Department of Endocrinology
city: Thessaloniki
country: Greece
facility: B IKA Panagia Hospital - Department of Endocrinology
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital, 28 Yongon-dong Chongno-gu
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital - Department of Endocrinology and Metabolism
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Samsung Medical Center
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital - Department of Endocrinology
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre - Department of Endocrinology
city: Utrecht
country: Netherlands
facility: UMC Utrecht - Department of Endocrinology, Heidelberglaan 100
city: Bergen
country: Norway
facility: Department of Medicine, Haukeland Hospital Jonas Lies
city: Kielce
country: Poland
facility: Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine
city: Krakow
country: Poland
facility: University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4
city: Cluj-Napoca
country: Romania
facility: University of Medicine and Pharmacy Iuliu Hatieganu
city: Moscow
country: Russian Federation
facility: Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department
city: Moscow
country: Russian Federation
facility: I.M. Sechenov Moscow Medical Academy - Endocrinology Department
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13
city: Novi Sad
country: Serbia
facility: Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9
city: Linkoping
country: Sweden
facility: EM-Kliniken, Universitetssjukhuset
city: Lund
country: Sweden
facility: Skane University Hospital, Department of Endocrinology
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: