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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022117
Receipt No. R000025499
Scientific Title Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer
Date of disclosure of the study information 2016/04/29
Last modified on 2018/10/24

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Basic information
Public title Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer
Acronym Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer
Scientific Title Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer
Scientific Title:Acronym Phase II study of lubiprostone for chemotherapy-induced constipation in patients with lung cancer
Region
Japan

Condition
Condition primary lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of lubiprostone for chemotherapy-induced constipation in patients with lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Change from screening period in bowel movements (BMs) frequency at week first after starting lubiprostone without rescue medication use
Key secondary outcomes Changes from screening period in BMs frequency at week 2 or more after starting lubiprostone without rescue medication use

Time to first BMs without rescue medication use

Percentage of patients with their first BMs within 24 and 48 hours after the dosage without rescue medication use

Changes from screening period of each parameter and total score in Constipation Scoring System

Change of the hardness in BMs (Bristol Stool Scale)

Time to first rescue medication use (Time to treatment failure)

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 oral lubiprostone 24mcg BID
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 Primary inclusion criteria
1) Histologically or cytologically confirmed lung cancer
2) First course or after second course chemotherapy or chemoradiotherapy including cytotoxic anticancer agent (Regardless of untreated or treated, before or after start of the regimen)

3) Aged 20 years or over
4) ECOG Performance Status 0-2
5) Keep a diary by oneself, and ability to answer a writing by oneself-style question paper
6) Adequate organ function, as

- Neutro. > or = 1,500/mm3
- Hemoglobin > or = 8.0g/dL
- Plt > or = 7.5x10,000/mm3
- AST/ALT < or = 100 IU/L
- T-bil < or = 1.5mg/dL
- Cre < or = 1.5mg/dL
- SpO2(Room air)> or = 90%
7) Life expectancy more than 3 months
8) Orally-available
9) Previously not received lubiprostone
10) Written informed consent from the patients


Secondary inclusion criteria
1) After starting chemotherapy of the primary registration, there is no BM more than three days, or there is a feeling of remaining BM even if there is a BM every day, and 2 or less in Bristol Stool Scale
2) Chemotherapy or chemoradiotherapy after the second registration and the primary registration are equivalence regimens
Key exclusion criteria Primary exclusion criteria
1) Only molecular target based agent (EGFR-TKI, ALK-TKI, VEGF inhibitor, immunotherapy)
2) Brain metastases with symptomatic or required for steroid and anticonvulsant

3) Mechanical bowel obstruction (e.g., tumor, hernia) or organic disorder of the large
or small bowel (e.g., obstruction, stenosis, inflammatory bowel disease)
4) Megacolon or Pseudo intestinal obstruction
5) Gastrointestinal or abdominal surgery for three months before registration
6) Severe complications (e.g., uncontrollable peptic ulcer, angina pectoris, cardiovascular disease, or infection)
7) Starting opioid within two weeks before primary registration
8) History of severe drug allergy
9) Inappropriate for this study judged by the attending doctor

Secondary exclusion criteria
1) Discontinuation of equivalence regimens for severe adverse events, except for dose reduction
2) Mechanical bowel obstruction (e.g., tumor, hernia) or organic disorder of the large
or small bowel (e.g., obstruction, stenosis, inflammatory bowel disease)
3) Severe complications (e.g., uncontrollable peptic ulcer, angina pectoris, cardiac disease, or infection)
4) Starting opioid within two weeks before secondary registration
5) Inappropriate for this study judged by the attending doctor
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seisuke Nagase
Organization International University of Health and Welfare, Mita hospital
Division name Respiratory Disease Center
Zip code
Address 1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL 03-3451-8121
Email snagase@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seisuke Nagase
Organization International University of Health and Welfare, Mita hospital
Division name Respiratory Disease Center
Zip code
Address 1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL 03-3451-8121
Homepage URL
Email snagase@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare, Mita hospital
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 国際医療福祉大学三田病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 29 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 14 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 28 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025499

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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