Trials / Completed
CompletedNCT02299089
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin® LAR®
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Camurus AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.
Detailed description
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms, treated for at least 2 months with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin LAR Last Dose Assessment Phase (Day -28).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | octreotide FluidCrystal® injection depot |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2016-05-01
- Completion
- 2016-06-01
- First posted
- 2014-11-24
- Last updated
- 2017-12-15
- Results posted
- 2017-12-15
Locations
10 sites across 4 countries: France, Germany, Italy, Sweden
Source: ClinicalTrials.gov record NCT02299089. Inclusion in this directory is not an endorsement.