Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
- Registration Number
- NCT00701363
- Lead Sponsor
- Ipsen
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lanreotide Autogel 120 mg Lanreotide Autogel 120 mg -
- Primary Outcome Measures
Name Time Method 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) At week 48 (End of Study) 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)
- Secondary Outcome Measures
Name Time Method 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) The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.
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 The criterion for a subject is satisfied if he extended his 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 IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) At baseline, week 24 and week 48 Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).
Mean Changes From Baseline in Quality of Life Scores (AcroQoL) At weeks 24 and 48 AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.
Mean Changes From Baseline in Quality of Life Scores (SF-36) At weeks 24 and 48 Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.
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 At week 48 (End of Study) The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.
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 At weeks 24 and 48 AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.
IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.
Correlation presented is a Spearman correlation (non parametric).Serum Growth Hormone (GH) Levels At Baseline, week 24 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) 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 Baseline (visit 1) Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL At weeks 24 and 48 Subject Treatment Schedule Preference At weeks 24 and 48 At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.
At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study).Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) At week 24 The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.
Trial Locations
- Locations (44)
University of Medicine and Pharmacy Iuliu Hatieganu
🇷🇴Cluj-Napoca, Romania
Polykliniki Hospital - Department of Endocrinology
🇬🇷Athens, Greece
B IKA Panagia Hospital - Department of Endocrinology
🇬🇷Thessaloniki, Greece
Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism
🇧🇷Sao Paulo, Brazil
Hôpital de Hautepierre, Service de Médecine Interne et Nutrition
🇫🇷Strasbourg, France
Sungkyunkwan University Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Odense University Hospital - Department of Endocrinology
🇩🇰Odense C, Denmark
Righospitalet - University Department of Endocrinology & Internal Medicine P
🇩🇰Copenhagen, Denmark
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besançon, 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
Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center
🇧🇷Rio de Janeiro, Brazil
Arhus University Hospital - Department of Medicinsk AVd M
🇩🇰Arhus C, Denmark
Hôpital Avicenne - Bâtiment Madeleine Breis
🇫🇷Bobigny, France
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 de Nîmes - Hôpital Caremeau
🇫🇷Nîmes, France
Hôpital Du Cluzeau - Service de Médecine B
🇫🇷Limoges, France
Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition
🇫🇷Paris, France
Hopital Pitié-Salpêtrière - Service d'Endocrinologie
🇫🇷Paris, France
Hôpital Haut Lévêque - Unité de soins normalisés
🇫🇷Pessac, France
Hôpital Robert Debré
🇫🇷Reims, France
Evangelismos Hospital - Department of Endocrinology
🇬🇷Athens, Greece
Metaxa Hospital - Department of Endocrinology
🇬🇷Piraeus, Greece
Seoul National University hospital, 28 Yongon-dong Chongno-gu
🇰🇷Seoul, Korea, Republic of
Yonsei University Severance Hospital - Department of Endocrinology and Metabolism
🇰🇷Seoul, Korea, Republic of
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
Skane University Hospital, Department of Endocrinology
🇸🇪Lund, Sweden
I.M. Sechenov Moscow Medical Academy - Endocrinology Department
🇷🇺Moscow, Russian Federation
Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13
🇷🇸Belgrade, Serbia
EM-Kliniken, Universitetssjukhuset
🇸🇪Linkoping, Sweden
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9
🇷🇸Novi Sad, Serbia
Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna
🇸🇪Stockholm, Sweden
Hôpital Archet 1 - Service d'Endocrinologie
🇫🇷Nice, France
CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B
🇫🇷Tours, France
Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon
🇫🇷Paris, France
Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department
🇷🇺Moscow, Russian Federation