UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.