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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00701363
First received: June 18, 2008
Last updated: November 10, 2015
Last verified: November 2015

June 18, 2008
November 10, 2015
October 2008
March 2013   (final data collection date for primary outcome measure)
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) [ Time Frame: At week 48 (End of Study) ] [ Designated as safety issue: No ]
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)
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 ]
Complete list of historical versions of study NCT00701363 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
    The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.
  • 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 (up to week 48) ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval [ Time Frame: Baseline (visit 1) and week 48 ] [ Designated as safety issue: No ]
    IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline
  • 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 [ Time Frame: Baseline (visit 1) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline (visit 1) ] [ Designated as safety issue: No ]
  • Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) [ Time Frame: At baseline, week 24 and week 48 ] [ Designated as safety issue: No ]
    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).
  • Mean Changes From Baseline in Quality of Life Scores (AcroQoL) [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: No ]
    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.
  • Mean Changes From Baseline in Quality of Life Scores (SF-36) [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: At week 48 (End of Study) ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: No ]

    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).

  • Serum Growth Hormone (GH) Levels [ Time Frame: At Baseline, week 24 and week 48 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Subject Treatment Schedule Preference [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: No ]

    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).

  • 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 ]
Not Provided
Not Provided
 
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
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
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
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Lanreotide Autogel 120 mg
120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24
Experimental: Lanreotide Autogel 120 mg
Intervention: Drug: Lanreotide Autogel 120 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
May 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Denmark,   Finland,   France,   Greece,   Korea, Republic of,   Latvia,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Serbia,   Sweden
 
NCT00701363
A-38-52030-214, 2007-005838-37
Not Provided
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Caroline Sert, MD Ipsen
Ipsen
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP