- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04804267
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation
March 17, 2021 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Clinical Equivalence of Two Linaclotide Products and the Efficacy and Safety of the Test Formulation of Linaclotide in the Treatment of Chronic Idiopathic Constipation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
750
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200127
- Recruiting
- Renji Hospital, Medical Collge of Shanghai Jiaotong University
-
Contact:
- Jingyuan Fang, Doctor
- Phone Number: 86-021-53882001
- Email: fangjingyuan_new@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or nonpregnant females aged ≥ 18 years with a clinical diagnosis of chronic idiopathic constipation defined as < 3 spontaneous bowel movements (SBMs) per week and confirmed by daily diary during baseline period;
Have 1 or more of the following symptoms related to bowel movements for the past 3 months with symptom onset at least 6 months before screening and confirmed by daily diary during the 2-week baseline period:
- lumpy or hard stools for more than 25% of the bowel movements (Bristol Stool Form Scale 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 laxatives used 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 affected CIC symptoms; Females of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study and until 30 days after the last dose; Males who have partners of childbearing potential agree to use effective contraceptive methods during the study and until 30 days after the last dose.
Exclusion Criteria:
- Meet the Rome IV criteria for Irritable Bowel Syndrome or the Rome IV criteria for Opioid-Induced Constipation; Have a potential central nervous system cause of constipation (e.g., Parkinson's disease, spinal cord injury, and multiple sclerosis, etc.); Have a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility; Subjects with documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction; Have ever had a fecal impaction that required hospitalization or emergency room treatment, or has a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment has been documented by a normal balloon expulsion test); Subjects with known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease); Subjects with constipation secondary to a documented cause (e.g., surgery, bowel resection); Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer; Have a history of cancer other than treated basal cell or squamous cell carcinoma of the skin in the past 5 years; Have currently unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], anemia, weight loss) or systemic signs of infection or colitis; Have currently active peptic ulcer disease; Have a history of diabetic neuropathy; Have untreated hypothyroidism or treated hypothyroidism 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 any chronic condition (e.g., chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis) that can be associated with abdominal pain or discomfort and could confound the assessments in this trial; Have clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities, ineligible to participate in the study as determined by the investigator; Have a history of drug or alcohol abuse in the past 12 months before screening; Bariatric surgery for treatment of obesity or surgery to remove a segment of the GI tract at any time before screening; any gastrointestinal or abdominal surgical procedure during the 3 months before screening; any other major surgery during the 30 days before screening; Use of systemic antibiotics within 4 weeks prior to enrolment; Unwilling or unable to abide by the restrictions regarding use of prohibited medicines; Have received any investigational drug during the 3 months before screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Linaclotide Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Drug: Linaclotide 145μg orally once daily
|
Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Drug: Linaclotide 145μg orally once daily
|
Active Comparator: Active Comparator
LINZESS® Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily
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Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily
|
Placebo Comparator: Placebo Comparator
Placebo Drug: Placebo orally once daily
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Drug: Placebo orally once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of spontaneous bowel movements (SBM) during Week 1
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of 12-Week complete spontaneous bowel movements (CSBMs) overall responders
Time Frame: 12 week
|
12 week
|
The number of CSBM during Week 1 compared to baseline
Time Frame: 1 week
|
1 week
|
The proportion of patients with a SBM within 24 hours of receiving the first dose
Time Frame: 24 hours after the first dose
|
24 hours after the first dose
|
Time to first SBM after the first dose
Time Frame: up to 1 week
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up to 1 week
|
The proportion of patients with 12-Week CSBM frequency rate (CSBMs/week) ≥3
Time Frame: 12 week
|
12 week
|
Change from baseline in 12-Week CSBM frequency rate (CSBMs/week)
Time Frame: 12 week
|
12 week
|
Change from baseline in 12-Week SBM frequency rate (SBMs/week)
Time Frame: 12 week
|
12 week
|
Change From Baseline in 12-Week Stool Consistency Assessment (seven-point ordinal Bristol Stool Form Scale)
Time Frame: 12 week
|
12 week
|
Change From Baseline in 12-Week Severity of Straining Assessment (five-point ordinal scale)
Time Frame: 12 week
|
12 week
|
Change From Baseline in 12-Week Abdominal Discomfort Assessment (five-point ordinal scale)
Time Frame: 12 week
|
12 week
|
Change From Baseline in 12-Week Bloating Assessment (five-point ordinal scale)
Time Frame: 12 week
|
12 week
|
Change From Baseline in 12-Week Constipation Severity Assessment (five-point ordinal scale)
Time Frame: 12 week
|
12 week
|
Change From Baseline in PAC-QOL score (Patient Assessment of Constipation Quality of Life questionnaire)
Time Frame: 12 week
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2021
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
March 10, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20078-501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Forest LaboratoriesIronwood Pharmaceuticals, Inc.CompletedConstipation | Chronic ConstipationUnited States, Canada
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Forest LaboratoriesIronwood Pharmaceuticals, Inc.Completed
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Forest LaboratoriesIronwood Pharmaceuticals, Inc.CompletedChronic ConstipationUnited States, Canada
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Astellas Pharma IncCompleted
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Ironwood Pharmaceuticals, Inc.Forest LaboratoriesCompletedIrritable Bowel Syndrome With ConstipationUnited States
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Astellas Pharma IncCompletedIrritable Bowel Syndrome With Constipation (IBS-C)Japan
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Ironwood Pharmaceuticals, Inc.CompletedIrritable Bowel Syndrome With ConstipationUnited States, Canada