Actively Recruiting
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Led by Third Military Medical University · Updated on 2026-01-20
346
Participants Needed
15
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lubiprostone has established efficacy and a favorable safety profile in chronic constipation and irritable bowel syndrome with constipation (IBS-C). However, clinical data specifically supporting its use in slow-transit constipation (STC), a distinct subtype of chronic constipation, remains limited.
CONDITIONS
Official Title
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participated in the study and provided signed informed consent
- Met the Rome IV diagnostic criteria for functional constipation
- Had fewer than 3 spontaneous bowel movements (SBMs) per week
- More than 20% of radio-paque markers localized in the colon after 72 hours based on colonic transit studies
- Were able to complete the bowel movement diary and study questionnaires as required by the study protocol
- Agreed to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug
- Aged 18 years or older, both males and females
You will not qualify if you...
- Pregnant or lactating women
- Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele > 3.1 cm, puborectalis syndrome)
- Patients with hyperthyroidism or hypothyroidism
- Patients with opioid-induced constipation
- Patients with megacolon or megarectum
- Patients with apparent mechanical intestinal obstruction
- Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis)
- Patients with malignant tumors of the digestive system
- Patients with a history of colorectal surgery
- Patients with a previous history of taking lubiprostone
- Patients with severe symptoms of depression or anxiety
- Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients
- Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants
- Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases
- Other patients deemed by the investigator as unsuitable for participation in this trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Bishan Hospital of Chongqing
Bishan, Chongqing Municipality, China, 402760
Not Yet Recruiting
2
the People's Hospital of HeChuan Chongqing
Hechuan, Chongqing Municipality, China, 401533
Not Yet Recruiting
3
Shapingba Hospital, Chongqing University
Shapingba, Chongqing Municipality, China, 400033
Not Yet Recruiting
4
The Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, Chongqing Municipality, China, 401331
Not Yet Recruiting
5
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China, 400042
Actively Recruiting
6
Gansu Province Central Hospital
Lanzhou, Gansu, China, 730079
Not Yet Recruiting
7
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150007
Not Yet Recruiting
8
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430062
Not Yet Recruiting
9
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China, 210002
Not Yet Recruiting
10
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China, 200127
Not Yet Recruiting
11
Xijing Hospital
Xi’an, Shanxi, China, 710032
Not Yet Recruiting
12
Chengdu Analrectal Hospital
Chengdu, Sichuan, China, 610017
Not Yet Recruiting
13
The General Hospital of Western Theater Command
Chengdu, Sichuan, China, 610036
Not Yet Recruiting
14
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644000
Not Yet Recruiting
15
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
Y
yansen Huang, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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