Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (LEAD)
Tracking Information| Start Date ICMJE | October 2008 |
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| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: June 18, 2008) | 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 ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00701363 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: January 30, 2009) | - 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 ]
- 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. [ Time Frame: During Phase 2 of the study and at Week 48 ] [ 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 ]
- Mean baseline IGF 1 levels versus mean baseline IGF 1 levels in subjects with uncontrolled IGF 1 levels [ Time Frame: At Week 24 ] [ 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 ]
- Changes in serum GH levels from baseline [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
- Adverse events (including local tolerance) and serious adverse event reporting rates [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Vital signs and physical examination findings recorded at baseline [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Gallbladder ultrasound [ Time Frame: At baseline and Week 48 ] [ Designated as safety issue: Yes ]
- Laboratory tests: standard haematology and biochemistry tests [ Time Frame: At baseline, Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Glucose tolerance based on fasting blood glucose [ Time Frame: At baseline, Week 24 and 48 ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE
(submitted: June 18, 2008) | - 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 ]
- 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. [ Time Frame: During Phase 2 of the study and at Week 48 ] [ 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 ]
- Mean baseline IGF 1 levels versus mean baseline IGF 1 levels in subjects with uncontrolled IGF 1 levels [ Time Frame: At Week 24 ] [ 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 ]
- Serum GH levels at baseline [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
- Adverse events (including local tolerance) and serious adverse event reporting rates [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Vital signs and physical examination findings recorded at baseline [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Gallbladder ultrasound [ Time Frame: At baseline and Week 48 ] [ Designated as safety issue: Yes ]
- Laboratory tests: standard haematology and biochemistry tests [ Time Frame: At baseline, Week 24 and 48 ] [ Designated as safety issue: Yes ]
- Glucose tolerance based on fasting blood glucose [ Time Frame: At baseline, Week 24 and 48 ] [ Designated as safety issue: Yes ]
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Descriptive Information| Brief Title ICMJE | Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects |
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| Official Title ICMJE | 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 |
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| 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 |
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| Detailed Description | |
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| Study Phase | Phase IV |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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| Condition ICMJE | Acromegaly |
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| Intervention ICMJE | Drug: Lanreotide Autogel 120 mg 120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24 |
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| Study Arms / Comparison Groups | 1: Experimental Intervention: Drug: Lanreotide Autogel 120 mg |
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Recruitment Information| Estimated Enrollment ICMJE | 150 |
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| Estimated Completion Date | November 2010 |
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| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | 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
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| Gender | Both |
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| Ages | 18 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | |
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| Location Countries ICMJE | Brazil, Denmark, Finland, France, Greece, Korea, Republic of, Latvia, Netherlands, Russian Federation, Sweden |
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Administrative Information| NCT ID ICMJE | NCT00701363 |
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| Responsible Party | Stefan Lempereur, Ipsen |
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| Study ID Numbers ICMJE | A-38-52030-214 |
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| Study Sponsor ICMJE | Ipsen |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Stefan Lempereur, MD | Ipsen | |
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| Information Provided By | Ipsen |
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