Ascites Clinical Trial
Official title:
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
NCT number | NCT00005906 |
Other study ID # | 000147 |
Secondary ID | 00-H-0147 |
Status | Completed |
Phase | Phase 2 |
First received | June 9, 2000 |
Last updated | April 29, 2010 |
Start date | June 2000 |
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. Treatment of many of these symptoms has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings have shown reduction in chylous effusions. This study assesses the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.
Status | Completed |
Enrollment | 4 |
Est. completion date | |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA: Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following: 1. lymphangioleiomyomas 2. chylous pleural effusions 3. peripheral lymph-edema 4. chyloptysis 5. protein-losing enteropathy 6. chyluria Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms. EXCLUSION CRITERIA: 1. Hypersensitivity to somatostatin, octreotide or its analogues 2. Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases 3. Transplant patients 4. Pregnant women or women who are beast-feeding 5. Patient or another responsible party is unable to give the subcutaneous injection 6. Patient unwilling to be followed per the guidelines set forth 7. Patients with decreased renal function (creatinine greater than 1.5) 8. Patients with HIV infection 9. Immunosuppressed patients |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Ulíbarri JI, Sanz Y, Fuentes C, Mancha A, Aramendia M, Sánchez S. Reduction of lymphorrhagia from ruptured thoracic duct by somatostatin. Lancet. 1990 Jul 28;336(8709):258. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. | 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%. | Six months | No |
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. | 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. |
Six months | No |
Secondary | Number of Participants With Liver Function Abnormalities | One or more abnormality of the following liver function tests: Alkaline phosphatase above 116 i.u. SGPT above 41 i.u. SGOT from 34 i.u. Total bilirubin above 1.0 mg/dl |
Six months | Yes |
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