Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation (STOPS 03)

January 16, 2026 updated by: Weidong Tong, Third Military Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Slow-transit constipation (STC) is a common subtype of chronic constipation, accounting for up to 30% of cases. Its clinical hallmarks include a diminished or absent urge to defecate and a significantly reduced stool frequency (spontaneous bowel movements <3 per week). The condition often follows a prolonged and progressively worsening course, characterized by straining, passage of hard stools, and associated symptoms such as abdominal pain and bloating. In severe cases, fecal impaction and consequent colonic obstruction may occur, substantially impairing the patient's quality of life.

Non-surgical management, including lifestyle modifications, pharmacological therapy, gut microbiome modulation, and sacral nerve stimulation, remains the first-line approach for most STC patients. Among these, pharmacotherapy is central. Conventional agents include bulk-forming, osmotic, and stimulant laxatives, as well as prokinetics. However, these options are often limited by adverse effects-such as abdominal pain, bloating, rash, drug dependence, malabsorption, and electrolyte imbalances-and the development of tolerance with long-term use. This frequently leaves patients with inadequate relief, creating an urgent need for more effective and safer therapeutics.

Lubiprostone, a chloride channel activator that functions as a secretagogue, enhances intestinal fluid secretion and motility. Its efficacy and safety in chronic idiopathic constipation and irritable bowel syndrome with constipation are well-documented, leading to approvals by the U.S. FDA for these indications. Nevertheless, specific data on its use for STC, a distinct pathophysiological entity, is lacking. This study is therefore designed to evaluate the clinical efficacy and safety of lubiprostone in an STC population, with the aim of generating new evidence to inform precise treatment strategies for this condition.

Study Type

Interventional

Enrollment (Estimated)

346

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Bishan, Chongqing Municipality, China, 402760
        • Not yet recruiting
        • Bishan Hospital of Chongqing
        • Contact:
          • Hong Chen, MD
          • Phone Number: 13908366079
      • Hechuan, Chongqing Municipality, China, 401533
        • Not yet recruiting
        • the People's Hospital of HeChuan Chongqing
        • Contact:
      • Shapingba, Chongqing Municipality, China, 400033
        • Not yet recruiting
        • Shapingba Hospital, Chongqing University
        • Contact:
      • Shapingba, Chongqing Municipality, China, 401331
        • Not yet recruiting
        • The Chenjiaqiao Hospital of ShaPingba District of Chongqing
        • Contact:
          • Chuan Zhao, MD
          • Phone Number: 13452949840
      • Yuzhong, Chongqing Municipality, China, 400042
        • Recruiting
        • Army Medical Center (Daping Hospital)
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730079
        • Not yet recruiting
        • Gansu Province Central Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150007
        • Not yet recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430062
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Not yet recruiting
        • General Hospital of the Eastern Theater Cammand of the PLA
        • Contact:
    • Shanghai Municipality
      • Pudong, Shanghai Municipality, China, 200127
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiaotong University
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China, 710032
        • Not yet recruiting
        • Xijing Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Not yet recruiting
        • Chengdu Analrectal Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610036
        • Not yet recruiting
        • The General Hospital of Western Theater Command
        • Contact:
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • The Second People's Hospital of Yibin
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lubiprostone
Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation.
Drug: Lubiprostone
Patients were instructed to orally ingest Lubiprostone Soft Capsules (provided by Nanjing Chia-Tai Tianqing Pharmaceutical Company) at a dose of 24 μg twice daily with food and water during breakfast and dinner. The capsules must be swallowed whole without splitting or chewing. The treatment duration was 4 weeks, and medication adherence was monitored through patient diaries and pill count of returned medication.
Active Comparator: Polyethylene Glycol
Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children.
Drug: Polyethylene glycol (PEG )
Subjects in the control group will receive the standard treatment of polyethylene glycol 4000 powder at a dosage of 10 g, twice daily. Each dose will be dissolved in 200-250 mL of water and administered orally for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week
Time Frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the weekly average number of SBMs reported during the first week after treatment initiation
From 2 weeks prior to the first dose through 4 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients with SBMs within 24 hours after the first intake of the study drug
Time Frame: Day 1 after treatment initiation
Day 1 after treatment initiation
Time to first SBM occurrence after treatment initiation
Time Frame: Up to 4 weeks after treatment initiation
Up to 4 weeks after treatment initiation
The percentage of patients reporting 3 or more SBMs/wk
Time Frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The percentage of patients achieving an increase of ≥1 SBMs/week from baseline
Time Frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the weekly average number of SBMs at weeks 2, 3, and 4
Time Frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the Bristol Stool Form Scale (BSFS) values for SBMs at weeks 1 and 4
Time Frame: The 1 and 4-week treatment period has been completed
The BSFS values can be described as the following 7 types: 1. separate hard lumps; 2. sausage-shaped but lumpy; 3. like a sausage but with cracks; 4. like a sausage, smooth and soft; 5. soft blobs with clear cut edges; 6. a mushy stool; and 7. watery.
The 1 and 4-week treatment period has been completed
The change from baseline in the ratings of straining associated with SBMs at weeks 1 and 4
Time Frame: The 1 and 4-week treatment period has been completed
The ratings of straining will be described using a 5-point Likert scale: 0= absent; 1= mild; 2= moderate; 3= severe; and 4= very severe
The 1 and 4-week treatment period has been completed
The change from baseline in the Wexner constipation score at weeks 1 and 4
Time Frame: The 1 and 4-week treatment period has been completed
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
The 1 and 4-week treatment period has been completed
The change from baseline in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score at weeks 1 and 4
Time Frame: The 1 and 4-week treatment period has been completed
The full PAC-QOL consists of 28 items rated on a 5-point Likert scale ("1" = Not at all / None of the time; "2" = A little bit / A little of the time; "3" = Moderately /Some of the time; "4" = Quite a bit / Most of the time; "5" = Extremely / All of the time)
The 1 and 4-week treatment period has been completed
The patients' satisfaction scores at weeks 1 and 4
Time Frame: The 1 and 4-week treatment period has been completed
The patients' satisfaction scores will be described using a 5-point Likert scale: 0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely
The 1 and 4-week treatment period has been completed
The rate of adverse reactions, including nausea, diarrhea, and abdominal pain.
Time Frame: Up to 4 weeks after treatment initiation
Up to 4 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Study Director: Weidong Tong, MD, Army Medical Center (Daping Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

September 28, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB20250919
  • 82370547 (Other Grant/Funding Number: National Natural Science Foundation of China Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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