NCT00616551CompletedPhase 3
Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ambrilia Biopharma, Inc.
- Enrollment
- 65
- Locations
- 6
- Primary Endpoint
- Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg
Study Overview
Brief Summary
The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be diagnosed with active acromegaly.
- •If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.
- •If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.
- •If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.
- •If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.
- •If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
- •The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.
Exclusion Criteria
- •Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.
- •Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
- •Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
- •Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
- •Subject who have any other condition that alters the growth hormone or IGF-1 levels.
- •Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
Arms & Interventions
A
Experimental
Intervention: C2L-OCT-01 PR, 30 mg (Drug)
B
Active Comparator
Intervention: Octreotide acetate prolonged release, 30 mg (Drug)
Outcomes
Primary Outcomes
Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg
Time Frame: Days 1, 28, 42, 56 and 84
Secondary Outcomes
- Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR(84 days)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Active, not recruiting
Phase 2
Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBMGlioblastomaNCT03452579David Peereboom90
Completed
Phase 3
A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT02302716Eli Lilly and Company493
Completed
Phase 1
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule FormulationHepatitis CNCT00947440Abbott18
Terminated
Phase 3
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir AloneHepatitis BNCT00376259Novartis43
Completed
Phase 3
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan ChildrenPlasmodium FalciparumNCT03452475University of Oxford219