Trial · NCT00005906
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
NCT00005906, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2010-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment With Octreotide in Patients With Lymphangioleiomyomatosis. Trials, record NCT00005906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005906
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
- NCT number
- NCT00005906
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Lymphangioleiomyomatosis, Lymphangiomyomas, Pleural Effusions, Ascites
- Interventions
- Octreotide
- First posted
- 2000-06-12
- Last updated
- 2010-04-30
- Results first posted
- 2010-04-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. | Six months | Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%. |
| Primary | Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms. | Six months | Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment. A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe. |
| Secondary | Number of Participants With Liver Function Abnormalities | Six months | One or more abnormality of the following liver function tests: 1. Alkaline phosphatase above 116 i.u. 2. SGPT above 41 i.u. 3. SGOT from 34 i.u. 4. Total bilirubin above 1.0 mg/dl |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. | Six months | Participants | NUMBER | |
| PRIMARY | Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms. | Six months | Four patients with lymphangioleiomyomatosis and lymphangioleiomyomas and chylous effusions treated with octreotide injections by the subcutaneous route to determine whether the size of the tumors and effusions decrease with the therapy | Participants | NUMBER |
| SECONDARY | Number of Participants With Liver Function Abnormalities | Six months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. | Octreotide | 0 | 5 | Participants | |
| Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms. | Octreotide | 1 | 5 | Participants | |
| Number of Participants With Liver Function Abnormalities | Octreotide | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide | 4 | |
| Overall Study | COMPLETED | Octreotide | 1 | |
| Overall Study | NOT COMPLETED | Octreotide | 3 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Liver function abnormalities | Gastrointestinal disorders | Octreotide | 1 | 4 | 1 |
| serious | Gastrointestinal disorders | Hepatobiliary disorders | Octreotide | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide | ||
| Total, other adverse events | Octreotide | 1 | 4 |
| Total, serious adverse events | Octreotide | 1 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 1973814 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00005906
GET https://conductscience.org/api/trials/v1/NCT00005906/registered