Related Experiment Video
Updated: May 26, 2025
Electroacupuncture Combined with Chinese Medicine Ironing Therapy for Functional Constipation
Published on: July 5, 2024
Efficacy and safety of elobixibat in patients with chronic constipation-A randomized, multicenter, double-blind,
Piyush Agarwal1, Brajesh Kumar Jha2, Jaganmohan Somagoni2
1Global Clinical Management, Dr. Reddy's Laboratories Pvt. Ltd, Hyderabad, 500 016, India. piyushagarwal@drreddys.com.
Background:
Elobixibat is a locally acting ileal bile acid transporter (IBAT) inhibitor that relieves functional constipation in patients by accelerating colonic transit. In this study, we aimed at determining the efficacy and safety of elobixibat for short-term treatment (two weeks) of chronic constipation in Indian patients.
Methods:
The present study was a randomized, double-blind, parallel-group, placebo-controlled, phase III study to evaluate efficacy and safety of elobixibat. The study planned to enroll patients with chronic constipation of at least six months' duration, satisfying Rome IV criteria for functional constipation. Following a run-in of approximately 14 days to confirm eligibility and determine baseline frequency of spontaneous bowel movements (SBMs), eligible patients were randomized 1:1 either to elobixibat or to placebo groups. The change in weekly frequency of spontaneous bowel movements (SBMs) at the end of treatment (week two) over baseline was the primary efficacy endpoint in this trial. Primary efficacy analyses were based on the modified intention-to-treat (mITT) population. This trial is registered at CTRI (Clinical Trial Registry of India).
Results:
Between April 2023 and December 2023, 150 patients were randomized into the two-week trial. In mITT population (n = 146 [elobixibat = 75 and placebo = 71]), the least square mean (LSM) difference between elobixibat (3.83) and placebo (2.68) was 1.15 (95% CI, 0.31, 1.99) demonstrating a statistically significant improvement (p = 0.008) in weekly frequency of SBMs (week two over baseline) with the use of elobixibat. The proportions of patients with a complete spontaneous bowel movement (CSBM) "response" was significantly higher with elobixibat (49.33%) compared to the placebo (26.76%) treatment (difference 22.57% [95% CI, 8.36%, 36.78%] [p = 0.005]). The most common adverse event (AE) was abdominal pain (elobixibat = 6 patients [7.89%] vs. placebo = 3 patients [4.05%]).
Conclusions:
Elobixibat was well tolerated and improved bowel movement frequency within two weeks of treatment in Indian patient population with chronic constipation.
Clinical Trial Registry Number:
CTRI/2022/10/046690.
More Related Videos
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
03:50Acupoint Application Combined with Acupoint Massage for Treating Constipation in a Patient with Chronic Obstructive Pulmonary Disease
Published on: August 18, 2023
Related Concept Videos
01:17Drugs for Treatment of Diarrhea-Predominant IBS
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
01:21Drugs for Treatment of Constipation-Predominant IBS
01:22Drugs Affecting GI Tract Motility: Bulk-Forming and Stimulant Laxatives
Bulk-forming laxatives, such as psyllium, methylcellulose, and polycarbophil, absorb water in the intestine, increasing stool bulk and promoting bowel movement. This...
01:30Irritable Bowel Syndrome II: Clinical Features and Diagnostic Evaluation
Irritable Bowel Syndrome (IBS) is classified into subtypes based on the predominant bowel habits as determined by the Bristol Stool Form Scale (BSFS). The subtypes are:
01:23Drugs Affecting GI Tract Motility: Serotonin Receptor Agonists
01:20Drugs Affecting GI Tract Motility: Other Laxatives
Osmotic or saline laxatives, like magnesium hydroxide or milk of...