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Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly (TULIPIA)

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ClinicalTrials.gov Identifier: NCT00994214
Recruitment Status : Terminated (Preliminary data from this study does not support expected inhibition of GH and IGF-1)
First Posted : October 14, 2009
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: BIM 23A760 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BIM 23A760 1 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 2 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 4 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 6 mg Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 6 ]

Secondary Outcome Measures :
  1. Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 3 ]
  2. Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [ Time Frame: At Month 1 ]
  3. Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 [ Time Frame: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 ]
    Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline

  4. Changes in IGF-1 [ Time Frame: Baseline (Day 1) and Month 6 ]
  5. Percentage Change in Ring Finger Circumference [ Time Frame: Baseline (Day 1) and Month 6 ]
    Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.

  6. Number of Subjects Reported Adverse Events During the Study [ Time Frame: Up to Visit 10 (An average of 6.5 Months) ]

    For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.

    TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.



Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994214


  Show 23 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Catherine Lesage, MD Ipsen
More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00994214     History of Changes
Other Study ID Numbers: 2-55-52060-003
First Posted: October 14, 2009    Key Record Dates
Results First Posted: February 10, 2016
Last Update Posted: February 10, 2016
Last Verified: November 2015

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Dopamine
Somatostatin
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists