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Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Plain-language guide to NCT02299089: phase 2 randomized trial of Octreotide, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02299089
- Phase
- phase 2
- Status
- completed
- Start
- 2015-01
- Completion (planned or actual)
- 2016-05
- Participants
- 12 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acromegaly; Neuroendocrine Tumors
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Octreotide.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 12 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients ≥18 years of age. Acromegaly currently treated with Sandostatin LAR. Male or female patients ≥18 years of age. Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing). Currently treated with Sandostatin LAR for symptom control.
The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: inadequate bone marrow function; abnormal coagulation or chronic treatment with warfarin or coumarin derivates; impaired liver, cardiac and/or renal function.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.
It started in 2015-01 with completion listed for 2016-05.
It ran at 10 sites in Italy (4), Germany (3), France (2) and Sweden (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Number of Adverse Events and Serious Adverse Events, CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) and CAM2029 Effect on Growth Hormone (GH) (Acromegaly).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Octreotide in 12 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.