Clinical trial NCT00994214: Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Official title: Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* IGF-1 ≥1.3 x upper limit normal (ULN)
* Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
* Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

Exclusion Criteria:

* The patient has received long acting somatostatin analogues within 6 months of study entry
* The patient has undergone radiotherapy at any time prior to study entry
* The time between pituitary surgery (if any) and study entry is less than 6 weeks
* The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Primary outcomes:
measure: Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
timeFrame: At Month 6
Secondary outcomes:
measure: Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
timeFrame: At Month 3
measure: Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
timeFrame: At Month 1
measure: Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
timeFrame: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
measure: Changes in IGF-1
timeFrame: Baseline (Day 1) and Month 6
measure: Percentage Change in Ring Finger Circumference
timeFrame: Baseline (Day 1) and Month 6
measure: Number of Subjects Reported Adverse Events During the Study
timeFrame: Up to Visit 10 (An average of 6.5 Months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pituitary Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital / Neuroendocrine Unit
state: Massachusetts
city: Portland
country: United States
facility: Oregon University, Dept. of Endocrinology and Neurosurgery
state: Oregon
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas de São Paulo
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, Clinic of Internal Medicine
city: Praha
country: Czechia
facility: General University Hospital, Clinic of Internal Medicine,
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
city: Marseille
country: France
facility: Hôpital de la Timone
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital "Santariskiu Klinikos"
city: Mexico City
country: Mexico
facility: UIM Endocrinología Experimental, Hospital de Especialidades
city: México City
country: Mexico
facility: Insituto Nacional de Neurologia y Neurocirugia
city: Rotterdam
country: Netherlands
facility: Department of Endocrinology, Erasmus MC
city: Rybnik
country: Poland
facility: Voivodeship Specialistic Hospital No 3
city: Bucharest
country: Romania
facility: "C.I. Parhon" National Institute of Endocrinology
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Kharkiv
country: Ukraine
facility: Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
city: Kyiv
country: Ukraine
facility: Administration of Medical Services and Rehabilitation of "ARTEM"
city: Vinnitsa
country: Ukraine
facility: National Medical University n.a. M.I.Pirogov
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: