Chronic Idiopathic Constipation Clinical Trial
Official title:
Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation
Verified date | May 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
Status | Completed |
Enrollment | 951 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male or female aged 18-75, inclusive - Body Mass Index = 18-35 kg/m2, inclusive - Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation. - Less than 3 CSBMs per week at baseline and during pretreatment - Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings - Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods - Willing to maintain a stable diet during the study. - Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study. Exclusion Criteria: - Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period - Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C) - Active peptic ulcer disease not adequately treated or not stable - History of cathartic colon, laxative, enema abuse, or ischemic colitis. - Fecal impaction within 3 months of screening - Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain - Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis. - Major surgery within 60 days of screening. |
Country | Name | City | State |
---|---|---|---|
United States | Albuquerque Clinical Trials, Inc | Albuquerque | New Mexico |
United States | Lovelace Scientific Resources, Inc | Albuquerque | New Mexico |
United States | ACRI-Phase 1,LLC | Anaheim | California |
United States | Heartland Research Associates, LLC | Augusta | Kansas |
United States | Gastroenterology Associates, LLC | Baton Rouge | Louisiana |
United States | Horizon Research Group, LLC | Baton Rouge | Louisiana |
United States | MediSpect, LLC | Boone | North Carolina |
United States | Boston Clinical Trials, Inc | Boston | Massachusetts |
United States | Consultants for Clinical Research of S. Florida | Boynton Beach | Florida |
United States | NY Total Medical Care | Brooklyn | New York |
United States | Synergy First | Brooklyn | New York |
United States | Investigators Research Group, LLC | Brownsburg | Indiana |
United States | Translational Research Group, INC., d/b/a Providence Clinical Research | Burbank | California |
United States | Valley Medical Research | Centerville | Ohio |
United States | East Valley Gastroenterology and Hepatology Associates, PC | Chandler | Arizona |
United States | Clinical and Translational Research Center Hospital | Chapel Hill | North Carolina |
United States | Carolina Digestive Health Associates | Charlotte | North Carolina |
United States | Ridgeview Research | Chaska | Minnesota |
United States | ClinSearch, LLC | Chattanooga | Tennessee |
United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
United States | Medex Healthcare Research, Inc. | Chicago | Illinois |
United States | New River Valley Research Institute | Christiansburg | Virginia |
United States | GW Research, Inc | Chula Vista | California |
United States | Iowa Digestive Disease Center | Clive | Iowa |
United States | Consultants in Gastroenerology | Columbia | South Carolina |
United States | Hometown Urgent Care | Columbus | Ohio |
United States | KRK Medical Research | Dallas | Texas |
United States | Research Across America | Dallas | Texas |
United States | Carolina Digestive Health Associates | Davidson | North Carolina |
United States | Hometown Urgent Care and Research | Dayton | Ohio |
United States | Gastro Specialists Research Center, LLC | Decatur | Georgia |
United States | Horizons Clinical Research Center, LLC | Denver | Colorado |
United States | CTL Research | Eagle | Idaho |
United States | Reasearch Across America | El Paso | Texas |
United States | Central Jersey Medical Research Center | Elizabeth | New Jersey |
United States | MediSphere Medical Research Center, LLC | Evansville | Indiana |
United States | NECCR Internal Medicine and Cardiology Associates, LLC | Fall River | Massachusetts |
United States | Internal Medical Associates of Grand Island, PC | Grand Island | Nebraska |
United States | Long Island Gastrointestinal Research Group LLP | Great Neck | New York |
United States | LeBauer Research Associates, PA | Greensboro | North Carolina |
United States | Medoff Medical / Vital re:Search | Greensboro | North Carolina |
United States | Hometown Urgent Care | Groveport | Ohio |
United States | Carolina Digestive Health Associates | Harrisburg | North Carolina |
United States | Clinical Research Partners, LLC | Henrico | Virginia |
United States | Associates in Gastroenterology | Hermitage | Tennessee |
United States | Medical Research Unlimited, LLC | Hialeah | Florida |
United States | Mid-Atlantic Medical Research Centers | Hollywood | Maryland |
United States | Gastroenterology Consultants | Houston | Texas |
United States | Pioneer Research Solutions, Inc. | Houston | Texas |
United States | Hutchinson Clinic, P.A | Hutchinson | Kansas |
United States | Nature Coast Clinical Research | Inverness | Florida |
United States | HCCA Clinical Research Solutions | Jackson | Tennessee |
United States | Health Awareness, Inc. | Jupiter | Florida |
United States | Jupiter Research, Inc. | Jupiter | Florida |
United States | Beyer Research | Kalamazoo | Michigan |
United States | The Center for Pharmaceutical Research, PC | Kansas City | Missouri |
United States | Research Across America | Katy | Texas |
United States | PMG Research of Knoxville | Knoxville | Tennessee |
United States | Memorial Health System, Inc., d/b/a LaPorte Medical Group | LaPorte | Indiana |
United States | Midwest Center for Clinical Research | Lee's Summit | Missouri |
United States | Preferred Research Partners, Inc | Little Rock | Arkansas |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia | Lynchburg | Virginia |
United States | South Jersey Gastroenterology, PA | Marlton | New Jersey |
United States | Great Lakes Gastroenterology | Mentor | Ohio |
United States | Advanced Clinical Research | Meridian | Idaho |
United States | Advance Medical Research Service | Miami | Florida |
United States | Advance Medical Research Service Corp | Miami | Florida |
United States | Columbus Clinical Services, LLC | Miami | Florida |
United States | Florida International Research Center | Miami | Florida |
United States | Miami Gastroenterology Consultants, PA | Miami | Florida |
United States | South Medical Research Group, Inc | Miami | Florida |
United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
United States | Burke Primary Care | Morgantown | North Carolina |
United States | St. Thomas Medical Group | Nashville | Tennessee |
United States | Women Under Study, LLC | New Orleans | Louisiana |
United States | Heartland Research Associates, LLC | Newton | Kansas |
United States | National Clinical Research-Norfolk, Inc | Norfolk | Virginia |
United States | Southwest Gastroenterology Assoc | Oak Lawn | Illinois |
United States | Clinical Research Associates, LLC | Oklahoma City | Oklahoma |
United States | Quality Clinical Research Inc. | Omaha | Nebraska |
United States | Community Clinical Trials | Orange | California |
United States | Compass Research, LLC | Orlando | Florida |
United States | Research Integrity | Owensboro | Kentucky |
United States | Digestive Health Center | Pasadena | Texas |
United States | Gold Coast Research, LLC | Plantation | Florida |
United States | Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York |
United States | Wake Research associates, LLC | Raleigh | North Carolina |
United States | Dormir Clinical Trials, Inc | Redlands | California |
United States | Inland Gastroenterology Medical Associates, Inc. | Redlands | California |
United States | National Clinical Research-Richmond, Inc. | Richmond | Virginia |
United States | Jeffrey Danzig | Ridgewood | New Jersey |
United States | Remedica LLC | Rochester | Michigan |
United States | Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois |
United States | Superior Research LLC | Sacramento | California |
United States | St. Louis Center for Clinical Research | Saint Louis | Missouri |
United States | Jean Brown Research | Salt Lake City | Utah |
United States | Utah Clinical Trials. LLC | Salt Lake City | Utah |
United States | Quality Research Inc. | San Antonio | Texas |
United States | Medical Associates Research Group, Inc. | San Diego | California |
United States | Medical Center for Clinical Research | San Diego | California |
United States | Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia |
United States | DMI Research | Seminole | Florida |
United States | Willis-Knighton Physician Network / Pinnacle Gastroenterology | Shreveport | Louisiana |
United States | Memorial Health System, Inc., d/b/a Ireland Road Medical Group | South Bend | Indiana |
United States | American Center for Clinical Trials | Southfield | Michigan |
United States | Spring Gastroenterology PA | Spring | Texas |
United States | Hometown Urgent Care and Research | Springfield | Ohio |
United States | Meridien Research | Tampa | Florida |
United States | Adobe Clinical Research, LLC | Tucson | Arizona |
United States | Desert Sun Clinical Research, LLC | Tucson | Arizona |
United States | Genova Clinical Research | Tucson | Arizona |
United States | North American Partners in Pain Management | Valley Stream | New York |
United States | Progressive Clinical Research | Vista | California |
United States | Advanced Clinical Research | West Jordan | Utah |
United States | Palm Beach Research Center | West Palm Beach | Florida |
United States | Heartland Research Associates, LLC | Wichita | Kansas |
United States | Heartland Research Associates, LLC | Wichita | Kansas |
United States | PMG Research of Wilmington | Wilmington | North Carolina |
United States | PMG Research of Winston-Salem | Winston-Salem | North Carolina |
United States | Paddu and Associates, LLP | Woodside | New York |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. | Parexel |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Responder 9/12 Weeks | A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. | 12-Week Treatment Period | |
Secondary | Change From Baseline in 12-week CSBM Weekly Frequency Rate | The number of Complete Spontaneous Bowel Movements (CSBMs) per week | 12-Week Treatment Period | |
Secondary | Change From Baseline in 12-week SBM Weekly Frequency Rate | The number of Spontaneous Bowl Movements experienced per week. | 12-Week Treatment Period | |
Secondary | Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period | The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7. = separate hard lumps like nuts (difficult to pass) = sausage shaped but lumpy = like a sausage but with cracks on its surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges (passed easily) = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces (entirely liquid) |
12-Week Treatment Period | |
Secondary | Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score | The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst | 12-Week Treatment Period |
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