Clinical Trial Results:
A Phase II, Single Centre, Randomized, Double-Blind, Parallel And Placebo Controlled, Pilot Study to Evaluate the Efficacy and Safety of Somatuline Autogel 60 mg in Patients with Active Thyroid-Associated Ophthalmopathy of Moderate Intensity
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Summary
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EudraCT number |
2004-003937-14 |
Trial protocol |
ES |
Global end of trial date |
27 Oct 2006
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2017
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First version publication date |
05 Jan 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A-92-52030-164
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00288522 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ipsen Pharma, S.A.
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Sponsor organisation address |
Avda. Laura Miro 395, 08980 Sant Feliu de Llobregat, Barcelona, Spain,
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Public contact |
Medical Director, Ipsen Pharma, S.A., clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Ipsen Pharma, S.A., clinical.trials@ipsen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Oct 2006
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Oct 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Oct 2006
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy and safety of 3 doses of Somatuline Autogel (60 milligram [mg]) in the control of the infiltration and oedema of the muscle and retrobulbar connective tissue and in the retraction and contraction of the extraocular musculature in patients with active thyroid-associated opthalmopathy of moderate intensity.
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Protection of trial subjects |
The clinical study was conducted in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice, under the ethical principles laid down in the Declaration of Helsinki. In addition, this clinical study adhered to all local regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jan 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was designed as a randomized, double-blind, parallel and placebo controlled study at a single investigational site in Spain. First patient enrolled: 20 January 2006; last patient completed: 27 October 2006. | |||||||||
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Pre-assignment
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Screening details |
The inclusion of 20 patients in the study was planned, but only 5 patients were enrolled over a period of 12 months and before the study was prematurely terminated. | |||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Somatuline Autogel | |||||||||
Arm description |
Somatuline Autogel 60 mg was administered by subcutaneous (s.c.) injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Somatuline Autogel
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Investigational medicinal product code |
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Other name |
lanreotide
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Treatment consisted of a single s.c. injection of Somatuline Autogel (60 mg, 0.25 millilitre [mL]), once every 28 days, on 3 separate visits (Day 0, Week 4 and Week 8).
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Arm title
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Placebo | |||||||||
Arm description |
Placebo (saline solution) was administered by s.c. injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Treatment consisted of a single s.c. injection of saline solution (0.25 mL), once every 28 days, on 3 separate visits (Day 0, Week 4 and Week 8).
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Baseline characteristics reporting groups
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Reporting group title |
Somatuline Autogel
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Reporting group description |
Somatuline Autogel 60 mg was administered by subcutaneous (s.c.) injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo (saline solution) was administered by s.c. injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Somatuline Autogel
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Reporting group description |
Somatuline Autogel 60 mg was administered by subcutaneous (s.c.) injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo (saline solution) was administered by s.c. injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | ||
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End point title |
Eye inspection (at Day 0 and Weeks 4, 8 and 12): assessment of conjunctival injection presence, chemosis, cheratitis and eyelid oedema; extrinsic muscle function evaluation and eyelid retraction [1] | |||||||||
End point description |
Assessment of the retraction and contraction of the extraocular musculature measuring the palpebral retraction by evaluation of the visual exam of the upper sclereocorneal limbo and visible adjacent sclerotic; and assessment of the function of the extraocular musculature by evaluation of the Hess Weiss's diagram (for motility) and with the Maddox cross (for diplopia).
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End point type |
Primary
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End point timeframe |
12 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed for this end point |
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| Notes [2] - Due to the small sample of patients, end point data was listed only. No summarised results reported. [3] - Due to the small sample of patients, end point data was listed only. No summarised results reported. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Extraocular muscle infiltration and oedema exam by evaluating (at Day 0 and Weeks 4, 8 and 12): extraocular muscle size, proptosis and intraocular pressure (tonometry) [4] | |||||||||
End point description |
Assessment of the oedema and the infiltration of the extraocular muscles and connective tissue measuring the extraocular muscle size by using orbital computerised tomography, assessment of the proptosis by using a Hertel's exophthalmometer and measurement of the intraocular pressure with a Perkin's tonometer.
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End point type |
Primary
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End point timeframe |
12 weeks
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed for this end point |
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| Notes [5] - Due to the small sample of patients, end point data was listed only. No summarised results reported. [6] - Due to the small sample of patients, end point data was listed only. No summarised results reported. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to Week 12
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Adverse event reporting additional description |
Adverse event (AE) data is reported as treatment-emergent AEs
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Somatuline Autogel
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Reporting group description |
Somatuline Autogel 60 milligram (mg) were administered by subcutaneous (s.c.) injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo (saline solution) was administered by s.c. injection once every 28 days. Duration of treatment was 12 weeks (3 doses received). Study treatment was administered in the upper external quadrant of the buttock, alternating right and left sides at every administration. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was prematurely terminated due to poor recruitment; 20 patients were planned but only 5 were included over a 12-month period. The limited efficacy data was listed only; no descriptive or inferential statistical analysis was performed. | |||
