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

This study has been terminated.
(Preliminary data from this study does not support expected inhibition of GH and IGF-1)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00994214
First received: October 13, 2009
Last updated: October 10, 2013
Last verified: October 2013

October 13, 2009
October 10, 2013
October 2009
January 2011   (final data collection date for primary outcome measure)
Proportion of patients with mean growth hormone (GH)≤2.5 ng/mL and normalised insulin-like growth factor-1 (IGF-1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00994214 on ClinicalTrials.gov Archive Site
  • Proportion of patients with mean GH≤2.5 ng/mL and normalised IGF-1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ring finger measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
  • Experimental: BIM 23A760 1 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 2 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 4 mg
    Intervention: Drug: BIM 23A760
  • Experimental: BIM 23A760 6 mg
    Intervention: Drug: BIM 23A760
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
108
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Czech Republic,   France,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Romania,   Sweden,   Ukraine
 
NCT00994214
2-55-52060-003
No
Ipsen
Ipsen
Not Provided
Study Director: Catherine Lesage, MD Ipsen
Ipsen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP