Lubiprostone for slow-transit constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized interventional trial enrolls adults with Rome IV–defined functional constipation and delayed colonic transit to compare lubiprostone with polyethylene glycol. Eligible participants have fewer than three spontaneous bowel movements per week and confirmed delayed transit by radio-opaque marker study. Participants will keep bowel movement diaries and complete symptom and safety questionnaires while receiving the assigned medication. The study will measure changes in bowel frequency, symptom relief, and adverse events to determine relative efficacy and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients voluntarily participated in the study and provided signed informed consent;
2. Met the Rome IV diagnostic criteria for functional constipation;
3. Had fewer than 3 spontaneous bowel movements (SBMs) per week;
4. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies;
5. Were able to complete the bowel movement diary and study questionnaires as required by the study protocol;
6. 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;
7. Aged 18 years or older, both males and females.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele \> 3.1 cm, puborectalis syndrome).
3. Patients with hyperthyroidism or hypothyroidism.
4. Patients with opioid-induced constipation.
5. Patients with megacolon or megarectum.
6. Patients with apparent mechanical intestinal obstruction.
7. Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
8. Patients with malignant tumors of the digestive system.
9. Patients with a history of colorectal surgery.
10. Patients with a previous history of taking lubiprostone.
11. Patients with severe symptoms of depression or anxiety.
12. Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients.
13. Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants.
14. Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases.
15. Other patients deemed by the investigator as unsuitable for participation in this trial.

Where it's running

• Shapingba Hospital, Chongqing University
  Shapingba, Chongqing Municipality, China Recruiting
• Army Medical Center (Daping Hospital)
  Yuzhong, Chongqing Municipality, China Recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• Renji Hospital, Shanghai Jiaotong University
  Pudong, Shanghai Municipality, China Recruiting
• Chengdu Analrectal Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: yansen Huang, MS
• Email: 1774651797@qq.com
• Phone: 8618630878656

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.