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โ† Trials
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Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation

RecruitingPhase 3Ages 18 Years - anyAllThird Military Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Lubiprostone
  • Polyethylene glycol (PEG )
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Where

20 sites
Bishan Hospital of Chongqing
Bishan, China
the People's Hospital of HeChuan Chongqing
Hechuan, China
Shapingba District Traditional Chinese Medicine Hospital in Chongqing
Shapingba, China
Shapingba Hospital, Chongqing University
Shapingba, China
The Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, China
Army Medical Center (Daping Hospital)
Yuzhong, China
Gansu Province Central Hospital
Lanzhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, China

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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