Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (LEAD)
This study is ongoing, but not recruiting participants.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00701363
First received: June 18, 2008
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Lanreotide Autogel 120 mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Percentage of subjects having maintained their injection interval schedule of six weeks or increased their injection interval to eight weeks whilst keeping their normalised IGF 1 levels (age and sex adjusted) [ Time Frame: At study end at Week 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects with normalised IGF 1 levels (age and sex adjusted) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
- Percentage of subjects having maintained an injection interval of six weeks or increasing their injection interval to eight weeks [ Time Frame: During Phase 2 of the study ] [ Designated as safety issue: No ]
- Mean change from baseline in IGF 1 values (expressed as % of ULN) overall and by injection interval [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
- Maintain normalised IGF 1 values [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
- Symptoms of acromegaly (headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia) [ Time Frame: At baseline, Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Mean changes from baseline in Quality of Life scores (AcroQoL* and SF 36) [ Time Frame: At Week 24 and Week 48 ] [ Designated as safety issue: No ]
| Enrollment: | 124 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lanreotide Autogel 120 mg |
Drug: Lanreotide Autogel 120 mg
120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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 GH 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701363
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| 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, Brazil | |
| Denmark | |
| Arhus University Hospital - Department of Medicinsk AVd M | |
| Arhus C, Denmark, DK 8000 | |
| Righospitalet - University Department of Endocrinology & Internal Medicine P | |
| Copenhagen, Denmark, DK-2100 | |
| Odense University Hospital - Department of Endocrinology | |
| Odense C, Denmark, DK-5000 | |
| Finland | |
| Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine | |
| Helsinki, Finland, 00290 | |
| Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division | |
| Kuopio, Finland, 70210 | |
| France | |
| CHU Besançon - Hôpital Jean Minjoz | |
| Besançon, France, 25030 | |
| Hôpital Avicenne - Bâtiment Madeleine Breis | |
| Bobigny, France, 93009 | |
| Hôpital Neurologique - Pierre Wertheimer | |
| Bron, France, 69677 | |
| Hôpital du Bocage Sud - Service d'Endocrinologie | |
| Dijon, France, 21079 | |
| CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition | |
| La Rochelle, France, 17019 | |
| Hôpital Du Cluzeau - Service de Médecine B | |
| Limoges, France, 87042 | |
| Hôpital Archet 1 - Service d'Endocrinologie | |
| Nice, France, 06200 | |
| CHU de Nîmes - Hôpital Caremeau | |
| Nîmes, France, 30029 | |
| Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon | |
| Paris, France, 75074 | |
| Hopital Pitié-Salpêtrière - Service d'Endocrinologie | |
| Paris, France, 75013 | |
| Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition | |
| Paris, France, 75010 | |
| Hôpital Haut Lévêque - Unité de soins normalisés | |
| Pessac, France, 33604 | |
| Hôpital Robert Debré | |
| Reims, France, 51092 | |
| Hôpital de Hautepierre, Service de Médecine Interne et Nutrition | |
| Strasbourg, France, 67098 | |
| CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B | |
| Tours, France, 37044 | |
| 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, Greece | |
| Korea, Republic of | |
| Sungkyunkwan University Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Yonsei University Severance Hospital - Department of Endocrinology and Metabolism | |
| Seoul, Korea, Republic of, 120-752 | |
| Seoul National University hospital, 28 Yongon-dong Chongno-gu | |
| Seoul, Korea, Republic of, 110-744 | |
| Latvia | |
| P. Stradins Clinical University Hospital - Department of Endocrinology | |
| Riga, Latvia, 1002 | |
| Netherlands | |
| Erasmus Medical Centre - Department of Endocrinology | |
| Rotterdam, Netherlands, NL-3015 CE | |
| UMC Utrecht - Department of Endocrinology, Heidelberglaan 100 | |
| Utrecht, Netherlands, NL-3584 CX | |
| Norway | |
| Department of Medicine, Haukeland Hospital Jonas Lies | |
| Bergen, Norway, N-5009 | |
| Poland | |
| Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine | |
| Kielce, Poland, 25-734 | |
| University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17 | |
| Krakow, Poland, 31501 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4 | |
| Wroclaw, Poland, 50-367 | |
| Romania | |
| University of Medicine and Pharmacy Iuliu Hatieganu | |
| Cluj-Napoca, Romania | |
| 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, Russian Federation | |
| Serbia | |
| Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13 | |
| Belgrade, Serbia, 11000 | |
| Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9 | |
| Novi Sad, Serbia, 21000 | |
| Sweden | |
| EM-Kliniken, Universitetssjukhuset | |
| Linkoping, Sweden, 581 85 | |
| Skane University Hospital, Department of Endocrinology | |
| Lund, Sweden, 221 85 | |
| Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna | |
| Stockholm, Sweden, 17176 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Xuan Mai TRUONG THANH, MD | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00701363 History of Changes |
| Other Study ID Numbers: | A-38-52030-214, 2007-005838-37 |
| Study First Received: | June 18, 2008 |
| Last Updated: | April 2, 2013 |
| Health Authority: | Sweden: Medical Products Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Latvia: State Agency of Medicines South Korea: Korea Food and Drug Administration (KFDA) Russia: Ministry of Health of the Russian Federation Greece: National Organization of Medicines Brazil: Ministry of Health Norway: Norwegian Medicines Agency Serbia and Montenegro: Agency for Drugs and Medicinal Devices Poland: Ministry of Health Romania: Ministry of Public Health |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013