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

Acromegaly Clinical Trial

— LEAD  

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

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
• Start date: October 2008
• Est. completion date: May 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Acromegaly

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