12-Week Study of Plecanatide for CIC (The CIC3 Study)

NCT01982240 | Completed Phase 3 Results

• 1 other identifier: SP304203-00
• Study Type: interventional
• Target: 1,394
• Locations: 2 countries
• Sites: 189

Brief Summary

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Conditions

Chronic Idiopathic Constipation

Keywords

CIC; Constipation; Chronic Constipation; Synergy; Plecanatide

Outcome Measures

Primary Outcomes (1)

• Number of Durable Overall CSBM Responders , Mean Replacement Approach

  A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.

  12-week Treatment Period

Secondary Outcomes (4)

• Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach

  12-Week Treatment Period

• Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach

  12-Week Treatment Period

• Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach

  12-Week Treatment Period

• Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach

  12-Week Treatment Period

Study Arms (4)

Plecanatide 3.0 mg

ACTIVE COMPARATOR

Plecanatide tablets 3.0 mg QD for 12 weeks

Drug: Plecanatide

Plecanatide 6.0 mg

ACTIVE COMPARATOR

Plecanatide tablets 6.0 mg QD for 12 weeks

Drug: Plecanatide

Placebo

PLACEBO COMPARATOR

Matching placebo tablets QD for 12 weeks

Drug: Placebo

Bisacodyl

OTHER

Rescue medication

Drug: Bisacodyl

Interventions

Plecanatide DRUG

Plecanatide tablets QD for 12 weeks

Also known as: Trulance

Plecanatide 3.0 mg; Plecanatide 6.0 mg

Placebo DRUG

Matching placebo tablets QD for 12 weeks

Also known as: Trulance placebo

Placebo

Bisacodyl DRUG

Rescue medication

Also known as: Dulcolax

Bisacodyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-80, inclusive
• Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
• Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings
• Willing to maintain a stable diet during the study

You may not qualify if:

• 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 pre-treatment assessment
• Active peptic ulcer disease, diabetes or hypertension 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, stroke or MI within 60 days of screening
• Participated in a previous plecanatide clinical trial

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (189)

Synergy Research Site

Birmingham, Alabama, 35242, United States

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Synergy Research Site

Dothan, Alabama, 36305, United States

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Synergy Research Site

Gulf Shores, Alabama, 36542, United States

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Synergy Research Site

Huntsville, Alabama, 35801, United States

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Synergy Research Site

Mobile, Alabama, 36695, United States

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Mesa, Arizona, 85206, United States

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Phoenix, Arizona, 85018, United States

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Phoenix, Arizona, 85023, United States

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Tempe, Arizona, 85283, United States

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Tucson, Arizona, 85712, United States

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Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72211, United States

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North Little Rock, Arkansas, 72117, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Carlsbad, California, 92008, United States

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Cerritos, California, 90703, United States

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Chula Vista, California, 91910, United States

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El Cajon, California, 92020, United States

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Encinitas, California, 92024, United States

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Encino, California, 91436, United States

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Fountain Valley, California, 92708, United States

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Fresno, California, 93726, United States

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Hawaiian Gardens, California, 90716, United States

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Lancaster, California, 93534, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90015, United States

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Los Angeles, California, 90045, United States

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Los Angeles, California, 90067, United States

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Mission Hills, California, 91345, United States

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Murrieta, California, 92562, United States

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North Hollywood, California, 91606, United States

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Oceanside, California, 92054, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Poway, California, 92064, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92101, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92114, United States

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Thousand Oaks, California, 91360, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Denver, Colorado, 80246, United States

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Littleton, Colorado, 80120, United States

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Bristol, Connecticut, 06010, United States

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Danbury, Connecticut, 06810, United States

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Waterbury, Connecticut, 06708, United States

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Boynton Beach, Florida, 33426, United States

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Clearwater, Florida, 33759, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33306, United States

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Fort Lauderdale, Florida, 33308, United States

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Hialeah, Florida, 33012, United States

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Jupiter, Florida, 33458, United States

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Lakeland, Florida, 33805, United States

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Lynn Haven, Florida, 32444, United States

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Miami, Florida, 33130, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33173, United States

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Miami, Florida, 33174, United States

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Miami, Florida, 33185, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32806, United States

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Port Orange, Florida, 32129, United States

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Tampa, Florida, 33604, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33617, United States

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Athens, Georgia, 30606, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30032, United States

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Decatur, Georgia, 30033, United States

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Johns Creek, Georgia, 30097, United States

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Oakwood, Georgia, 30566, United States

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Savannah, Georgia, 31406, United States

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Smyrna, Georgia, 30082, United States

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Evanston, Illinois, 60201, United States

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Clive, Iowa, 50325, United States

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Augusta, Kansas, 67010, United States

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Newton, Kansas, 67114, United States

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Shawnee Mission, Kansas, 66218, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40504, United States

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Bastrop, Louisiana, 71220, United States

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Marrero, Louisiana, 70072, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70115, United States

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New Orleans, Louisiana, 70119, United States

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Shreveport, Louisiana, 71103, United States

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Chevy Chase, Maryland, 20815, United States

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Boston, Massachusetts, 02131, United States

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Brockton, Massachusetts, 02302, United States

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New Bedford, Massachusetts, 02740, United States

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Chesterfield, Michigan, 48047, United States

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Flint, Michigan, 48504, United States

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Rochester, Michigan, 48307, United States

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Saginaw, Michigan, 48604, United States

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Southfield, Michigan, 48034, United States

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Biloxi, Mississippi, 39531, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63128, United States

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Omaha, Nebraska, 68114, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89121, United States

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Reno, Nevada, 89511, United States

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Lebanon, New Hampshire, 03756, United States

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Lodi, New Jersey, 07644, United States

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Ocean City, New Jersey, 07712, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11206, United States

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Great Neck, New York, 11023, United States

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North Massapequa, New York, 11758, United States

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Cary, North Carolina, 27518, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28210, United States

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Charlotte, North Carolina, 28277, United States

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Greensboro, North Carolina, 27403, United States

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Kinston, North Carolina, 28501, United States

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Raleigh, North Carolina, 27612, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Beavercreek, Ohio, 45432, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45246, United States

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Hilliard, Ohio, 43026, United States

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Huber Heights, Ohio, 45424, United States

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Maumee, Ohio, 43537, United States

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Mentor, Ohio, 44060, United States

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Oakwood, Ohio, 45419, United States

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Stow, Ohio, 44224, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73102, United States

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Limerick, Pennsylvania, 19468, United States

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Philadelphia, Pennsylvania, 19152, United States

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Smithfield, Pennsylvania, 15478, United States

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Yardley, Pennsylvania, 19067, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 28406, United States

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Columbia, South Carolina, 29204, United States

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Chattanooga, Tennessee, 37421, United States

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Jackson, Tennessee, 38305, United States

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Nashville, Tennessee, 37205, United States

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New Tazewell, Tennessee, 37825, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77043, United States

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Houston, Texas, 77062, United States

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Houston, Texas, 77070, United States

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Houston, Texas, 77090, United States

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Killeen, Texas, 76543, United States

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Plano, Texas, 75093, United States

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San Angelo, Texas, 76904, United States

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San Antonio, Texas, 78209, United States

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San Antonio, Texas, 78258, United States

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Sugar Land, Texas, 77479, United States

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Logan, Utah, 84341, United States

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Salt Lake City, Utah, 84124, United States

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St. George, Utah, 84790, United States

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Christiansburg, Virginia, 24073, United States

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Henrico, Virginia, 23233, United States

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Lynchburg, Virginia, 24502, United States

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Norfolk, Virginia, 23502, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23455, United States

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Seattle, Washington, 98105, United States

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Tacoma, Washington, 98405, United States

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Wauwatosa, Wisconsin, 53226, United States

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Kelowna, British Columbia, V1Y 1Z9, Canada

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Bridgewater, Nova Scotia, B4V 3N2, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Cambridge, Ontario, N1S 2M6, Canada

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Greater Sudbury, Ontario, P3E 1H5, Canada

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London, Ontario, N5Y 5K7, Canada

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Oshawa, Ontario, L1H 1B9, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Related Publications (5)

• Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.

  PMID: 37332239 DERIVED

• Rao SSC, Laitman AP, Miner PB Jr. Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00598. doi: 10.14309/ctg.0000000000000598.

  PMID: 37162147 DERIVED

• Moshiree B, Schoenfeld P, Franklin H, Rezaie A. The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials. Clin Ther. 2022 Jan;44(1):98-110.e1. doi: 10.1016/j.clinthera.2021.11.009. Epub 2022 Jan 25.

  PMID: 35086735 DERIVED

• Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.

  PMID: 32660770 DERIVED

• Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH. A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation. Am J Gastroenterol. 2017 Apr;112(4):613-621. doi: 10.1038/ajg.2016.611. Epub 2017 Feb 7.

  PMID: 28169285 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

plecanatide; Bisacodyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Patrick H. Griffin
• Organization: Synergy Pharmaceuticals Inc.

212-297-0020

Study Officials

• Mary Beth Layton

  Synergy Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 26, 2019
• Results First Posted: March 21, 2019

Record last verified: 2019-12

Locations

US (177); CA (12)