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Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Plain-language guide to NCT00005906: phase 2 interventional trial of Octreotide, 4 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00005906
- Phase
- phase 2
- Status
- completed
- Start
- 2000-06
- Completion (planned or actual)
- 2008-04
- Participants
- 4 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Lymphangioleiomyomatosis; Lymphangiomyomas; Pleural Effusions; Ascites
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Octreotide.
Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas).
Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas.
It had 1 arm (groups): Octreotide (experimental).
The registry classes the interventions as drug.
More on the Plan
Within the LAM patient population is a subset of patients who develop chylous ascites, chylous pleural effusions, chyluria, peripheral lymphedema, and/or lymphangioleiomyomas.
The lymphangioleiomyomas may occur anywhere along the axial lymphatic chain.
In patients with LAM, they occur most frequently in the thorax, abdomen and pelvis and may give rise to a myriad of symptoms (e.g., paresthesias, palpitations, peripheral edema).
Who Took Part
The registry lists 4 actual participants took part.
It was open to women only aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Chylous pleural effusions.
The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: hypersensitivity to somatostatin, octreotide or its analogues; transplant patients; pregnant women or women who are beast-feeding.
How the Study Was Run
Design: 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 2000-06 with completion listed for 2008-04.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Number of Participants With Liver Function Abnormalities.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in 4 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.