Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation

Recruiting now · Phase 3

Conditions studied: Slow Transit Constipation, Pharmacotherapy

In brief

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.

Key facts

Study ID

NCT07277907

Run by

Third Military Medical University

People needed

346

Starts

2025-11-13

Expected to finish

2027-11-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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% the 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 may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• Chengdu Analrectal Hospital — Chengdu, Sichuan, China (enrolling)
• The General Hospital of Western Theater Command — Chengdu, Sichuan, China (enrolling)
• Shapingba Hospital, Chongqing University — Shapingba, Chongqing Municipality, China (enrolling)
• Army Medical Center (Daping Hospital) — Yuzhong, Chongqing Municipality, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• Renji Hospital, Shanghai Jiaotong University — Pudong, Shanghai Municipality, China (enrolling)
• General Hospital of the Eastern Theater Cammand of the PLA — Nanjing, Jiangsu, China
• Xijing Hospital — Xi’an, Shanxi, China
• Mianyang 404 Hospital — Mianyang, Sichuan, China
• Pengzhou People's Hospital — Pengzhou, Sichuan, China
• The Second People's Hospital of Yibin — Yibin, Sichuan, China
• Bishan Hospital of Chongqing — Bishan, Chongqing Municipality, China
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China
• the People's Hospital of HeChuan Chongqing — Hechuan, Chongqing Municipality, China
• Shapingba District Traditional Chinese Medicine Hospital in Chongqing — Shapingba, Chongqing Municipality, China
• The Chenjiaqiao Hospital of ShaPingba District of Chongqing — Shapingba, Chongqing Municipality, China
• Gansu Province Central Hospital — Lanzhou, Gansu, China
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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