Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07277907

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here