CTRI/2022/10/046690RecruitingPhase 3
A randomized, multicentre, double blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of elobixibat once daily of Dr. Reddy’s laboratories limited in patients with chronic constipation
Dr Reddys Laboratories Limited16 sites in 1 country150 target enrollmentStarted: November 30, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 16
- Primary Endpoint
- Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)
Study Overview
Brief Summary
This study is planned to evaluate the efficacy, and safety of Elobixibat tablet (10 mg oral once daily administered as two tablets of 5 mg) in patients with chronic constipation. Male and non-pregnant female subjects (18-65 years of age) with clinical diagnosis of chronic constipation will be included in the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female patients of 18-65 years age
- •Ambulatory patients with chronic constipation (fulfilling Rome IV criteria) reporting <3 Spontaneous Bowel Movements (SBM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative:.
- •Straining during more than 25% of defecations.
- •Lumpy or hard stools more than 25% of defecations.
- •Sensation of incomplete evacuation more than 25% of defecations
- •Patients with less than 3 SBM per week during pretreatment period.
- •Willing to comply with protocol requirements and sign a statement of informed consent
- •Willing to discontinue any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories)
- •Agreed to refrain from making any new, major life-style changes that may have affected CIC symptoms (e.g., starting a new diet or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit.
- •Female subjects of: Child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period (acceptable methods include intrauterine device, barrier or abstinence). OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). OR Postmenopausal for at least 1 year.
Exclusion Criteria
- •Pregnant, breast feeding, or planning a pregnancy
- •Subject of any age with evidence of clinically significant weight loss, anemia, or rectal bleeding and without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within 2 years period prior to screening.
- •Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of bowel movements.
- •Reported a Bristol Stool Form Scale score of 6 (loose, mushy stools) for > 1 SBM or a Bristol Stool Form Scale score of 7 (watery stools) with any SBM over the 2 weeks pretreatment period before the Randomization Visit.
- •Received a diagnosis of inflammatory bowel disease (IBD)
- •Meet the Rome IV criteria for Irritable Bowel Syndrome (IBS) or the Rome IV criteria for Opioid-Induced Constipation (OIC)
- •Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility.
- •Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, mega colon, mega rectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer.
- •Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer
- •Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy)
- •Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis
- •Has a potential central nervous system (CNS) cause of constipation
- •Has intestinal/rectal prolapse or other known pelvic floor dysfunction
- •Commonly uses digital maneuvers (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement
- •Has a history of diabetic neuropathy
- •Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit, surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit, an appendectomy or cholecystectomy during the 60 days before the Screening Visit, other major surgery during the 30 days before the Screening Visit.
- •Has a history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix
- •Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection
- •Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening
- •History of alcohol or drug abuse during the 6 months prior to Screening
- •Reported using a Prohibited Medicine (excluding laxatives, suppositories, and enemas) during the Pretreatment Period or was not willing or able to abide by the restrictions regarding use of Prohibited Medicines (Note: The use of fiber, bulk laxatives, or stool softeners [such as docusate] was acceptable provided the patient had been on a stable dose during the 30 days before the Screening Visit and planned to continue on a stable dose throughout the trial).
- •Patients having following lab parameters deranged defined as follows: -Renal function: Serum Creatinine ≥1.5 × upper limit of normal (ULN).
- •Hepatic function: AST and ALT ≥3 × ULN;.
- •Hemoglobin: < 8g/dL
- •Has a clinically significant laboratory finding or medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator.
Outcomes
Primary Outcomes
Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)
Time Frame: Week 1 And Week 2
Secondary Outcomes
- Proportion of patients with complete spontaneous bowel movement (CSBM)(Week 1 And Week 2)
- Proportion of patients with a Spontaneous Bowel Movement within 24 h after the first dose of study drug(With in 24 hour)
- Median time to first Spontaneous Bowel Movement(First timepoint to Spontaneous Bowel Movement)
- Change from baseline in Stool consistency using Bristol Stool Form Scale(Week 1 and week 2)
- Change from Baseline in Weekly Degree of Straining of Spontaneous Bowel Movement(Week 1 And Week 2)
- Change from Baseline in Weekly Abdominal Bloating Score(Week 1 And Week 2)
- Change from Baseline in Weekly Abdominal Discomfort Score(Week 1 And Week 2)
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Completed
Phase 2
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASHNASHNAFLDNCT04006145Albireo47
Recruiting
Phase 4
Comparing Two Medicines for Chronic Constipation: Elobixibat vs. PrucaloprideConstipation,CTRI/2025/04/085075Dayanand Medical College and Hospital150
Completed
Phase 3
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal AntibodyPrimary Hyperlipidemia and Mixed DyslipidemiaNCT02189837Amgen89
Withdrawn
Phase 2
BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisMicroscopic PolyangiitisGranulomatosis With PolyangiitisNCT01598857Anthera Pharmaceuticals
Completed
Phase 3
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisNCT03773978Eli Lilly and Company220