Shouhui Tongbian Capsule Phase 3 OIC Trial in Cancer Patients
Summary
NIH ClinicalTrials.gov registered Phase 3 trial NCT07534995 for Shouhui Tongbian Capsule in treating opioid-induced constipation (OIC) in cancer patients. The prospective, multicenter, randomized, parallel-controlled superiority trial will evaluate symptom-relieving effects including defecation frequency, stool consistency, symptom scores, and quality of life. Primary efficacy endpoint is proportion of responders at week 2, defined as increase of at least 1 in average weekly spontaneous bowel movements. Safety endpoints include adverse event incidence and vital sign changes.
What changed
NIH registered a new Phase 3 clinical trial for Shouhui Tongbian Capsule, an investigational treatment for opioid-induced constipation in cancer patients. The trial will enroll participants and compare the investigational capsule against Lactulose over a 2-week treatment period, measuring spontaneous bowel movements, stool consistency, symptom scores, and quality of life outcomes. Safety monitoring includes adverse events, vital signs, and laboratory assessments.
Pharmaceutical companies and clinical research organizations conducting oncology trials should note this additional Phase 3 program in the OIC treatment space. Healthcare providers treating cancer patients with opioid analgesics may wish to identify trial sites for patient referral options. The trial's focus on intestinal flora mechanisms may provide future insights into constipation management in this patient population.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
Phase 3 NCT07534995 Kind: PHASE3 Apr 16, 2026
Abstract
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...
Conditions: OIC
Interventions: the Shouhui Tongbian Capsule, Lactulose
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