UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022117 |
|---|---|
| Receipt number | 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 | 2022/11/02 10:54:40 |
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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 | Seisuke |
| Middle name | |
| Last name | Nagase |
Organization
International University of Health and Welfare, Mita hospital
Division name
Respiratory Disease Center
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
snagase@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Seisuke |
| Middle name | |
| Last name | Nagase |
Organization
International University of Health and Welfare, Mita hospital
Division name
Respiratory Disease Center
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
Homepage URL
snagase@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Mita hospital
Institute
Department
Personal name
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
International University of Health and Welfare, Mita hospital, IRB
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
Tel
03-3451-8121
rinri-mita@iuhw.ac.jp
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
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025499
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