Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation

Last updated: March 17, 2021
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Irritable Bowel Syndrome (Ibs)

Constipation

Treatment

N/A

Clinical Study ID

NCT04804267
HS-20078-501
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to evaluate the clinical equivalence of the test formulation of Linaclotide compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation, and to evaluate the efficacy and safety of the test formulation of Linaclotide in the treatment of Chronic Idiopathic Constipation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or nonpregnant females aged ≥ 18 years with a clinical diagnosis of chronicidiopathic constipation defined as < 3 spontaneous bowel movements (SBMs) per week andconfirmed by daily diary during baseline period; Have 1 or more of the following symptoms related to bowel movements for the past 3 monthswith symptom onset at least 6 months before screening and confirmed by daily diary duringthe 2-week baseline period:
  • lumpy or hard stools for more than 25% of the bowel movements (Bristol Stool FormScale 1 to 2)
  • sensation of incomplete evacuation following more than 25% of the bowel movements
  • straining at defecation more than 25% of the time Willing to discontinue any laxativesused before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine;Agree to refrain from making any new major life-style changes that may have affectedCIC symptoms; Females of child-bearing potential have a negative pregnancy test priorto beginning therapy and agree to use effective contraceptive methods during the studyand until 30 days after the last dose; Males who have partners of childbearingpotential agree to use effective contraceptive methods during the study and until 30days after the last dose.

Exclusion

Exclusion Criteria:

  • Meet the Rome IV criteria for Irritable Bowel Syndrome or the Rome IV criteria forOpioid-Induced Constipation; Have a potential central nervous system cause ofconstipation (e.g., Parkinson's disease, spinal cord injury, and multiple sclerosis,etc.); Have a structural abnormality of the gastrointestinal (GI) tract or a diseaseor condition that can affect GI motility; Subjects with documented mechanical bowelobstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, ordiagnosis of pseudo-obstruction; Have ever had a fecal impaction that requiredhospitalization or emergency room treatment, or has a history of cathartic colon,laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unlesssuccessful treatment has been documented by a normal balloon expulsion test); Subjectswith known or suspected organic disorders of the large or small bowel (e.g.,inflammatory bowel disease, ulcerative colitis, Crohn's Disease); Subjects withconstipation secondary to a documented cause (e.g., surgery, bowel resection);Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposiscolorectal cancer, or any other form of familial colorectal cancer; Have a history ofcancer other than treated basal cell or squamous cell carcinoma of the skin in thepast 5 years; Have currently unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], anemia, weight loss) orsystemic signs of infection or colitis; Have currently active peptic ulcer disease;Have a history of diabetic neuropathy; Have untreated hypothyroidism or treatedhypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the Screening Visit; Have a history of diverticulitis or anychronic condition (e.g., chronic pancreatitis, polycystic kidney disease, ovariancysts, endometriosis) that can be associated with abdominal pain or discomfort andcould confound the assessments in this trial; Have clinically significantcardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinicallysignificant laboratory abnormalities, ineligible to participate in the study asdetermined by the investigator; Have a history of drug or alcohol abuse in the past 12months before screening; Bariatric surgery for treatment of obesity or surgery toremove a segment of the GI tract at any time before screening; any gastrointestinal orabdominal surgical procedure during the 3 months before screening; any other majorsurgery during the 30 days before screening; Use of systemic antibiotics within 4weeks prior to enrolment; Unwilling or unable to abide by the restrictions regardinguse of prohibited medicines; Have received any investigational drug during the 3months before screening.

Study Design

Total Participants: 750
Study Start date:
March 05, 2021
Estimated Completion Date:
August 31, 2022

Study Description

This is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the clinical equivalence of the test formulation of Linaclotide (manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.) compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation.

Connect with a study center

  • Renji Hospital, Medical Collge of Shanghai Jiaotong University

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

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