UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	acromegaly and pituitary gigantism
Classification by specialty	Endocrinology and Metabolism Neurosurgery
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	Medicine
Interventions/Control_1	Octreotide LAR 10mg-40mg
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
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
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.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Soji Kasayama
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
Email

Public contact
Name of contact person	1st name Middle name Last name Soji Kasayama
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
Email	kasayama@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Kansai Study Groups for Hypothalamic and Pituitary Diseases
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation	2005 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2007 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 10 Month 04 Day
Last modified on	2005 Year 10 Month 15 Day

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

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