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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:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00701363
First received: June 18, 2008
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show 44 Study Locations
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 June 17, 2013