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

Ipsen23 sites in 13 countries109 target enrollmentOctober 2009

ConditionsAcromegaly

InterventionsBIM 23A760

DrugsBIM 23A760

Overview

Phase: Phase 2
Intervention: BIM 23A760
Conditions: Acromegaly
Sponsor: Ipsen
Enrollment: 109
Locations: 23
Primary Endpoint: Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

February 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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

Arms & Interventions

BIM 23A760 1 mg

Intervention: BIM 23A760

BIM 23A760 2 mg

Intervention: BIM 23A760

BIM 23A760 4 mg

Intervention: BIM 23A760

BIM 23A760 6 mg

Intervention: BIM 23A760

Outcomes

Primary Outcomes

Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

Time Frame: At Month 6

Secondary Outcomes

Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1(At Month 1)
Number of Subjects Reported Adverse Events During the Study(Up to Visit 10 (An average of 6.5 Months))
Percentage Change in Ring Finger Circumference(Baseline (Day 1) and Month 6)
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6(0-3 hr on Baseline (Day 1) and Months 1, 3 and 6)
Changes in IGF-1(Baseline (Day 1) and Month 6)