OICPhase 3NCT07534995

A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial

A Phase 3 study testing the Shouhui Tongbian Capsule and Lactulose in people with OIC, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: OIC
What is being tested?: the Shouhui Tongbian Capsule and Lactulose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: No sites listed yet
Study dates: 30 May 2026to 30 Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must meet the diagnostic criteria for opioid-induced constipation (OIC) according to the Rome IV Criteria.
Patients enrolled in the trial must have a history of OIC symptoms for at least 1 week.
Patients must be aged ≥ 18 years and ≤ 85 years.
Patients must have stable cancer status with a life expectancy of more than 6 months.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Patients must be on a relatively stable maintenance regimen of opioids, including a daily morphine-equivalent dose of 30 mg to 1000 mg for at least 2 weeks prior to the screening period. In addition, opioid therapy is expected to continue for at least 10 weeks.

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Patients must have a spontaneous bowel movement (SBM) frequency of ≤ 2 times per week without laxative use.
Patients must be able to take medications, food, and fluids orally.
Voluntarily participate in the trial and have signed the informed consent form.
No use of any prokinetic agents for at least 1 week prior to randomization.

Who cannot join

Patients diagnosed with clinically significant defecation disorders at enrollment caused by structural abnormalities of the gastrointestinal tract and other gastrointestinal-related tissues (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis or peritoneal tumors.
Patients with a history of gastrointestinal surgery, abdominal surgery or abdominal adhesions within 1 month before screening; or a history of intestinal obstruction within 3 months before screening.
Diagnosis of active diverticular disease; or severe hemorrhoids; or anal fissure; or artificial rectum or anus.
Patients with intra-abdominal catheters or feeding tubes.
Diagnosis of pelvic diseases considered to significantly affect intestinal transit of feces (e.g., uterine prolapse ≥ grade 2, uterine fibroids [located posteriorly with diameter ≥ 5 cm] affecting defecation).
Patients who received a new chemotherapy regimen never used before within 14 days after screening, or who planned to receive such treatment during the study period.

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Patients who received radiotherapy within 28 days after screening or planned to receive such treatment during the study period.
Patients who underwent surgery or intervention considered to significantly affect gastrointestinal function within 28 days after screening, or planned to undergo such surgery or intervention during the study period, or planned to undergo surgery or intervention expected to prevent completion of the trial.
Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection or coagulation disorders (hypercoagulable state or bleeding tendency) at study enrollment.
Patients who took >4 additional opioid doses per day for breakthrough pain for more than 3 days during the baseline period, or who modified the maintenance opioid dosing regimen during this period.
Patients with severe cancer pain unresponsive to opioid therapy at regular doses and frequencies (e.g., typical mean daily pain intensity rating of 7 to 10 on the Numerical Rating Scale (NRS; 0 [no pain] to 10 [worst possible pain])).
Patients with a history of opioid discontinuation due to serious adverse events, or for whom opioid discontinuation is anticipated due to potential risk of adverse events.
Patients treated with opioid receptor antagonists within 1 month before screening.
Unconsciousness, psychosis, or inability to express subjective symptoms.
Patients who have participated in or are participating in other clinical trials within the past 3 months.
Other patients considered ineligible for the study by the investigator based on concomitant treatments and medical findings.

About this study

Official title: A Randomized Controlled Clinical Study of Shouhui Tongbian Capsule in the Treatment of Opioid-Induced Constipation

This study intends to design and conduct a prospective, multicenter, randomized, parallel-controlled, superiority trial to evaluate the symptom-relieving effects of Shouhui Tongbian Capsule on opioid-induced constipation (OIC) in cancer patients, including defecation frequency, stool consistency, symptom scores, quality of life and other indicators, and to systematically observe its safety in clinical application. Through analysis of intestinal flora, the mechanism of Shouhui Tongbian Capsule in regulating intestinal function will be revealed. By screening the optimal population for Shouhui Tongbian Capsule in the treatment of OIC, evidence will be provided for optimizing individualized medication.

The primary efficacy endpoint is the proportion of responders at week 2 of treatment, defined as an increase of ≥1 in the average weekly number of spontaneous bowel movements (SBMs) compared with baseline and at least one SBM during that week. Secondary endpoints include weekly number of SBMs, weekly number of complete spontaneous bowel movements (CSBMs), Bristol Stool Form Scale score, straining score, Patient Assessment of Constipation-Symptoms (PAC-SYM) score, and Patient Assessment of Constipation-Quality of Life (PAC-QOL) score.

Safety endpoints mainly include the incidence of adverse events and changes in vital signs, electrocardiography, routine blood and urine tests, as well as liver and renal function before and after treatment. Meanwhile, based on clinical study data, the characteristics of the optimal population for Shouhui Tongbian Capsule in treating OIC will be identified to further enrich the application scenarios of this capsule for OIC.

Conditions: OIC
Being tested: the Shouhui Tongbian Capsule, Lactulose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the Shouhui Tongbian CapsuleDrug
Administered orally: Shouhui Tongbian Capsule (specification: 0.35 g per capsule), 2 capsules each time, 3 times daily
LactuloseDrug
Lactulose Oral Solution (specification: 100mL: 66.7 g), administered orally, 15 mL each time, twice daily.

Study groups in NCT07534995
Study group	Role	What they receive
the Shouhui Tongbian Capsule group	Experimental	Not described Receives: Drug: the Shouhui Tongbian Capsule
the lactulose group	Active comparator	Not described Receives: Drug: Lactulose

What is being measured

The primary outcome is the main question the study is designed to answer.

SBM
Responders were defined as having at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM from baseline for at least 6 out of the 8 treatment weeks.
An SBM was defined as a bowel movement occurring within the preceding 24 hours without any medications or interventions to facilitate defecation.
Bowel movements occurring within 24 hours of using rescue laxatives or other adjunctive defecation methods were not considered SBMs.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202630 Dec 2027

First posted16 Apr 2026
Study start30 May 2026 (estimated)
Primary completion30 Dec 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OICStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 270 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07534995
Sponsor's protocol ID: CACMREZZ2025-A-10
Status last verified: Apr 2026
First submitted: 10 Apr 2026
Last updated: 27 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Constipation, Opioid-Induced
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)
Not yet recruitingPhase 4
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
Opioid-Induced Constipation, Pain Cancer

All OIC trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Clinical Study of Shouhui Tongbian Capsule in the Treatment of Opioid-Induced Constipation
ClinicalTrials.gov ID: NCT07534995
Acronym / sponsor ID: CACMREZZ2025-A-10
Conditions: OIC
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 270 participants (estimated)
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
Study start: 30 May 2026 (estimated)
Primary completion: 30 Dec 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 16 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
the Shouhui Tongbian Capsule group	Experimental	Drug: the Shouhui Tongbian Capsule
the lactulose group	Active comparator	Drug: Lactulose

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Must meet the diagnostic criteria for opioid-induced constipation (OIC) according to the Rome IV Criteria.
Patients enrolled in the trial must have a history of OIC symptoms for at least 1 week.
Patients must be aged ≥ 18 years and ≤ 85 years.
Patients must have stable cancer status with a life expectancy of more than 6 months.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Key exclusion criteria (16 listed)

Patients diagnosed with clinically significant defecation disorders at enrollment caused by structural abnormalities of the gastrointestinal tract and other gastrointestinal-related tissues (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis or peritoneal tumors.
Patients with a history of gastrointestinal surgery, abdominal surgery or abdominal adhesions within 1 month before screening; or a history of intestinal obstruction within 3 months before screening.
Diagnosis of active diverticular disease; or severe hemorrhoids; or anal fissure; or artificial rectum or anus.
Patients with intra-abdominal catheters or feeding tubes.
Diagnosis of pelvic diseases considered to significantly affect intestinal transit of feces (e.g., uterine prolapse ≥ grade 2, uterine fibroids [located posteriorly with diameter ≥ 5 cm] affecting defecation).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
the Shouhui Tongbian CapsuleAdministered orally: Shouhui Tongbian Capsule (specification: 0.35 g per capsule), 2 capsules each time, 3 times daily	Drug	the Shouhui Tongbian Capsule group
LactuloseLactulose Oral Solution (specification: 100mL: 66.7 g), administered orally, 15 mL each time, twice daily.	Drug	the lactulose group

Primary outcome

SBM
Time frame: 2 weeks
Responders were defined as having at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM from baseline for at least 6 out of the 8 treatment weeks. An SBM was defined as a bowel movement occurring within the preceding 24 hours without any medications or interventions to facilitate defecation. Bowel movements occurring within 24 hours of using rescue laxatives or other adjunctive defecation methods were not considered SBMs.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.

Related trials for OIC

RecruitingPhase 4
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Constipation, Opioid-Induced
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)
Not yet recruitingPhase 4
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
Opioid-Induced Constipation, Pain Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing the Shouhui Tongbian Capsule and Lactulose in people with OIC, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SBM (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07534995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.