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Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Plain-language guide to NCT00432068: phase 1 interventional trial of Octreotide, 48 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00432068
- Phase
- phase 1
- Status
- completed
- Start
- 2007-01
- Completion (planned or actual)
- 2010-06
- Participants
- 48 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Cholecystectomized
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Octreotide.
It had 1 arm (groups): Octreotide pamoate (experimental).
The registry classes the interventions as drug.
Who Took Part
48 actual participants took part.
It was open to people of any sex aged from 18 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study. In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening. Body mass index within 19-29 kg/m2. Able to communicate well with the investigator and comply with the requirements of the study.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated); history of immunocompromise, including a positive hiv; known positive hepatitis b or c surface antigen (hbsag) or hepatitis c test result (anti-hcv).
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-01 with completion listed for 2010-06.
It ran at 6 sites in France (3), Belgium (2) and Italy (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring (time frame: 48 hrs post study drug administration).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Octreotide in 48 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.