Phase 4
N=128
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT00701363 ↗Enrolled (actual)
128
Serious AEs
8.9%
Results posted
Dec 2015
Primary outcome: 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) — 75.8; 86.2 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lanreotide Autogel 120 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
75.8; 86.2 | — |
| SECONDARY Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) |
88.7; 100 | — |
| SECONDARY Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks |
78.2; 88.1 | — |
| SECONDARY Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels |
20.2; 22.9 | — |
| SECONDARY Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval |
-1.70; 5.74; -4.33 | 0.0013 sig |
| SECONDARY 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 |
98.69; 67.75; 51.30 | 0.0009 sig |
| SECONDARY 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 |
95.92; 67.49; 28.43 | 0.0103 sig |
| SECONDARY Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) |
2.73; 2.15; 1.80; 2.04; 2.80; 1.92 | — |
| SECONDARY Mean Changes From Baseline in Quality of Life Scores (AcroQoL) |
21.59; -2.15; -0.27; -0.84; -0.35; NA | — |
| SECONDARY Mean Changes From Baseline in Quality of Life Scores (SF-36) |
-0.66; 4.91; 1.79; -2.75; 1.03; NA | — |
| SECONDARY 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 |
44.4; 47.2; 38.1; 44.6 | — |
| SECONDARY 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 |
0.43; -0.02; -0.41; -0.01; 0.69; -0.06 | — |
| SECONDARY Serum Growth Hormone (GH) Levels |
1.04; 0.92; 0.92; 1.08; 0.97; 4.89 | — |
| SECONDARY Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL |
66.7; 100.0; 91.4; 100.0; 93.8; 100.0 | — |
| SECONDARY Subject Treatment Schedule Preference |
20; 80; 7.7; 92.3; 10.3; 85.3 | — |
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
Eligibility 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, 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
Data sourced from ClinicalTrials.gov (NCT00701363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.