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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00701363
Other study ID # A-38-52030-214
Secondary ID 2007-005838-37
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2008
Est. completion date May 2013

Study information

Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date May 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil 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
Denmark 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
Finland 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
France 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 Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon Paris
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 Hôpital de Hautepierre, Service de Médecine Interne et Nutrition Strasbourg
France CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B Tours
Greece 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
Korea, Republic of Seoul National University hospital, 28 Yongon-dong Chongno-gu Seoul
Korea, Republic of Sungkyunkwan University Samsung Medical Center Seoul
Korea, Republic of Yonsei University Severance Hospital - Department of Endocrinology and Metabolism Seoul
Latvia P. Stradins Clinical University Hospital - Department of Endocrinology Riga
Netherlands Erasmus Medical Centre - Department of Endocrinology Rotterdam
Netherlands UMC Utrecht - Department of Endocrinology, Heidelberglaan 100 Utrecht
Norway Department of Medicine, Haukeland Hospital Jonas Lies Bergen
Poland 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
Romania University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca
Russian Federation Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department Moscow
Russian Federation I.M. Sechenov Moscow Medical Academy - Endocrinology Department Moscow
Serbia 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
Sweden EM-Kliniken, Universitetssjukhuset Linkoping
Sweden Skane University Hospital, Department of Endocrinology Lund
Sweden Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Brazil,  Denmark,  Finland,  France,  Greece,  Korea, Republic of,  Latvia,  Netherlands,  Norway,  Poland,  Romania,  Russian Federation,  Serbia,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24. At week 24
Secondary Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks 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. During phase 2 of the study (up to week 48)
Secondary Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels 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. At week 48
Secondary Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline Baseline (visit 1) and week 48
Secondary 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)
Secondary 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)
Secondary Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) 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). At baseline, week 24 and week 48
Secondary Mean Changes From Baseline in Quality of Life Scores (AcroQoL) 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. At weeks 24 and 48
Secondary Mean Changes From Baseline in Quality of Life Scores (SF-36) 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. At weeks 24 and 48
Secondary 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 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. At week 48 (End of Study)
Secondary 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 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).
At weeks 24 and 48
Secondary Serum Growth Hormone (GH) Levels At Baseline, week 24 and week 48
Secondary Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL At weeks 24 and 48
Secondary Subject Treatment Schedule Preference 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).
At weeks 24 and 48
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