Lubiprostone for slow-transit constipation

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial

This will test whether lubiprostone helps adults with slow-transit constipation compared with polyethylene glycol.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 15 sites (Bishan, Chongqing Municipality and 14 other locations)
• Trial ID: NCT07277907 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with Rome IV functional constipation, fewer than three spontaneous bowel movements per week, and delayed colonic transit (>20% radio-opaque markers remaining at 72 hours) who can complete study diaries are ideal candidates.

Not a fit: Patients with severe outlet obstruction, opioid-induced constipation, thyroid dysfunction, megacolon, or who are pregnant or lactating are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, lubiprostone could provide a more effective and well-tolerated medication option to increase bowel movements and reduce symptoms for adults with slow-transit constipation.

How similar studies have performed: Lubiprostone has proven efficacy and a favorable safety profile in chronic idiopathic constipation and IBS-C, but clinical data specifically for slow-transit constipation are limited.

Eligibility criteria

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 this trial is running

Bishan, Chongqing Municipality and 14 other locations

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

Study contacts

• Study coordinator: yansen Huang, MS

Conditions Slow Transit Constipation; Pharmacotherapy; Lubiprostone; Polyethylene Glycol; Randomized Controlled Trial; medication