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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | C000000258 |
Receipt No. | R000000322 |
Scientific Title | Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism |
Date of disclosure of the study information | 2005/10/05 |
Last modified on | 2005/10/15 |
Basic information | ||
Public title | Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism | |
Acronym | Effects of octreotide LAR treatment on QOL in acromegalic patients | |
Scientific Title | Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism | |
Scientific Title:Acronym | Effects of octreotide LAR treatment on QOL in acromegalic patients | |
Region |
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Condition | |||
Condition | acromegaly and pituitary gigantism | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data will be investigated in patients with acromegaly and pituitary gigantism to whom octreotiede LAR has not been given for recent six months. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. QOL(SF-36)
2. Clinical symptom(headache, sweating, arthralgia, carpal-tunnel syndrome, and other clinical symptoms) 3. Serum GH 4. Serum IGF-1 |
Key secondary outcomes | 1. Complication(blood pressure, glucose tolerance status, dyslipidemia, and cardiovascular diseases
2. Adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Octreotide LAR 10mg-40mg | |
Interventions/Control_2 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) The age is 20 years old or more.
2) Patients diagnosed with acromegaly or pituitary gigantism according to the criteria by |
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Key exclusion criteria | 1) Patients who have previous history of hypersensitivity for elements of Octreotide.
2) Patients whose serum bilirubin or serum creatinine concentration exceeds three times of the upper level of normal ranges. 3) Patients whose AST(GOT) or ALT(GPT) concentration exceeds five times of the upper level of normal ranges. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka University Graduate School of Medicine | ||||||
Division name | Department of Medicine (Endocrinology and Metabolism)(C-4) | ||||||
Zip code | |||||||
Address | 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan | ||||||
TEL | 06-6879-3831 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Osaka University Graduate School of Medicine | ||||||
Division name | Department of Medicine (Endaocrinology and Metabolism)(C-4) | ||||||
Zip code | |||||||
Address | 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan | ||||||
TEL | 06-6879-3831 | ||||||
Homepage URL | |||||||
kasayama@imed3.med.osaka-u.ac.jp |
Sponsor | |
Institute | Kansai Study Groups for Hypothalamic and Pituitary Diseases |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000322 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |