Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name LEAD

NCTNCT00701363Other idA-38-52030-214Other id2007-005838-37

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 124 participants (actual)
Sponsor: Ipsen · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 14 countries
Brazil, Denmark, Finland, France, Greece, Latvia, Netherlands, Norway, Poland, Romania, Russia, Serbia, South Korea, Sweden
Start: Oct 2008
Primary completion: Mar 2013
Completion: May 2013
First posted: 19 Jun 2008 (estimated)
Last update posted: 29 Jan 2019
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011201220132014

Ph 4
LEAD
NCT00701363
Oct 2008 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Lanreotide Autogel 120 mgDrug

Arms1

Experimental
Lanreotide Autogel 120 mg

Primary outcomes1

Outcomes the sponsor listed as 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)
Time frame · At week 48 (End of Study)
Registry description
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)

Secondary outcomes(14)

Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
Time frame · At week 24
Registry description
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)
Registry description
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
Registry description
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
Registry description
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)
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)
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Time frame · At baseline, week 24 and week 48
Registry description
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
Registry description
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
Registry description
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)
Registry description
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
Registry description
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
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
Time frame · At weeks 24 and 48
Subject Treatment Schedule Preference
Time frame · At weeks 24 and 48
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At week 48 (End of Study)

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)

Group	Value (Percentage of subjects)
Overall Study	75.8

Secondary and other outcome results(7)

Secondary outcomeNumber· At week 24

Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)

Group	Value (Percentage of subjects)
Overall Study	88.7

Secondary outcomeNumber· During phase 2 of the study (up to week 48)

Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

Group	Value (Percentage of subjects)
Overall Study	78.2

Secondary outcomeNumber· At week 48

Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels

Group	Value (Percentage of subjects)
Overall Study	20.2

Secondary outcomeMean· Baseline (visit 1) and week 48

Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval

Group	Value (Percentage of ULN)	Spread
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	-1.70	18.55
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks	5.74	30.48
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks	-4.33	28.14

Secondary outcomeMean· Baseline (visit 1)

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

Group	Value (Percentage of ULN)
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	98.69
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks	67.75
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks	51.30

Secondary outcomeMean· Baseline (visit 1)

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

Group	Value (Percentage of ULN)
Overall Study	95.92

Secondary outcomeMean· At baseline, week 24 and week 48

Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)

Group	Value (Units on a scale)	Spread
Phase 1 Only: Lanreotide Autogel 120 mg	2.73	2.71
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	2.15	1.72
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks	1.80	1.73
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks	2.04	2.11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Phase 1: Lanreotide Autogel 120 mgSubjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.	–	3 / 15	12 / 15
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 WeeksSubjects with IGF-1 levels \>100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.	–	2 / 13	10 / 13
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 WeeksSubjects with IGF-1 levels \>50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.	–	4 / 70	48 / 70
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 WeeksSubjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.	–	2 / 26	20 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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