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

NCT02122471 | Completed Phase 3 Results

• 1 other identifier: SP304203-03
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 167

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

  The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including 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 the 12-week Treatment Period , Mean Replacement Approach

  Baseline and 12 weeks

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

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach

  Baseline and 12 weeks

Study Arms (3)

Plecanatide 3.0 mg

EXPERIMENTAL

Plecanatide tablets 3.0 mg QD for 12 weeks

Drug: Plecanatide

Placebo

PLACEBO COMPARATOR

Matching placebo tablets QD for 12 weeks

Drug: Placebo

Plecanatide 6.0 mg

EXPERIMENTAL

Plecanatide tablets 6.0 mg QD for 12 weeks

Drug: Plecanatide

Interventions

Plecanatide DRUG

Plecanatide 3.0 mg; Plecanatide 6.0 mg

Placebo DRUG

Placebo

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 American Gastroenterological Association (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 Bowel Movements (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 myocardial infarction (MI) within 60 days of screening
• Participated in a previous plecanatide clinical trial

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (167)

Synergy Research Site

Anniston, Alabama, 36207, United States

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Synergy Research Site

Huntsville, Alabama, 35801, United States

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Synergy Research Site

Chandler, Arizona, 85224, United States

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Synergy Research Site

Goodyear, Arizona, 85395, United States

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Synergy Research Site

Tucson, Arizona, 85704, United States

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Synergy Research Site

Tucson, Arizona, 85710, United States

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Synergy Research Site

Tucson, Arizona, 85712, United States

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Synergy Research Site

Tucson, Arizona, 85715, United States

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Synergy Research Site

Tucson, Arizona, 85745, United States

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Anaheim, California, 92801, United States

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Artesia, California, 90701, United States

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Carmichael, California, 95608, United States

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Corona, California, 92879, United States

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Encino, California, 91436, United States

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Garden Grove, California, 92843, United States

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Garden Grove, California, 92844, United States

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Glendale, California, 91204, United States

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La Mirada, California, 90638, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90036, United States

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Newport Beach, California, 92663, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Sacramento, California, 95821, United States

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Sacramento, California, 95831, United States

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San Bernardino, California, 92408, United States

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San Diego, California, 92103, United States

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Upland, California, 91786, United States

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Ventura, California, 93003, United States

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Denver, Colorado, 80209, United States

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Littleton, Colorado, 80128, United States

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Stamford, Connecticut, 06905, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33472, United States

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Bradenton, Florida, 34208, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33312, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33012, United States

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Synergy Research Site

Hialeah, Florida, 33013, United States

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Synergy Research Site

Hialeah, Florida, 33016, United States

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Hialeah, Florida, 33106, United States

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Hollywood, Florida, 33024, United States

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Homestead, Florida, 33030, United States

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Jacksonville, Florida, 32256, United States

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Jacksonville, Florida, 32277, United States

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Miami, Florida, 33014, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33032, United States

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Miami, Florida, 33122, United States

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Synergy Research Site

Miami, Florida, 33125, United States

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Synergy Research Site

Miami, Florida, 33126, United States

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Miami, Florida, 33142, United States

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Synergy Research Site

Miami, Florida, 33144, United States

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Synergy Research Site

Miami, Florida, 33155, United States

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Synergy Research Site

Miami, Florida, 33157, United States

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Synergy Research Site

Miami, Florida, 33165, United States

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Synergy Research Site

Miami, Florida, 33173, United States

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Synergy Research Site

Miami, Florida, 33175, United States

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Miami, Florida, 33176, United States

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Miami, Florida, 33185, United States

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Miami Lakes, Florida, 33016, United States

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Miami Springs, Florida, 33166, United States

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New Port Richey, Florida, 34653, United States

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North Miami Beach, Florida, 33162, United States

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Orlando, Florida, 32806, United States

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Synergy Research Site

Orlando, Florida, 32807, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33026, United States

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Synergy Research Site

Pembroke Pines, Florida, 33028, United States

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Plant City, Florida, 33563, United States

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Plantation, Florida, 33324, United States

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Saint Cloud, Florida, 34769, United States

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Sarasota, Florida, 34242, United States

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Seminole, Florida, 33777, United States

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St. Petersburg, Florida, 33709, United States

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Tamarac, Florida, 33319, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33614, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30342, United States

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Savannah, Georgia, 31406, United States

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Snellville, Georgia, 30078, United States

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Blackfoot, Idaho, 83221, United States

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Boise, Idaho, 83709, United States

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Chicago, Illinois, 60602, United States

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Oak Lawn, Illinois, 60453, United States

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Schaumburg, Illinois, 60194, United States

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Evansville, Indiana, 47714, United States

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Madisonville, Kentucky, 42431, United States

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Owensboro, Kentucky, 42303, United States

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Monroe, Louisiana, 71201, United States

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Shreveport, Louisiana, 71105, United States

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Columbia, Maryland, 21045, United States

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Watertown, Massachusetts, 02472, United States

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Buckley, Michigan, 49620, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89103, United States

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Las Vegas, Nevada, 89106, United States

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Stateline, Nevada, 89449, United States

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Newington, New Hampshire, 03801, United States

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Blackwood, New Jersey, 08012, United States

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Albuquerque, New Mexico, 87102, United States

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Albuquerque, New Mexico, 87109, United States

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Elmsford, New York, 10523, United States

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New Hyde Park, New York, 11040, United States

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Synergy Research Site

New York, New York, 10016, United States

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Synergy Research Site

New York, New York, 10018, United States

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Cary, North Carolina, 27518, United States

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Concord, North Carolina, 28025, United States

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Hickory, North Carolina, 28601, United States

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Hickory, North Carolina, 28602, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45224, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43214, United States

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Kettering, Ohio, 45429, United States

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Middleburg Heights, Ohio, 44130, United States

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Sylvania, Ohio, 43560, United States

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Wadsworth, Ohio, 44203, United States

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Oklahoma City, Oklahoma, 73103, United States

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Synergy Research Site

Oklahoma City, Oklahoma, 73104, United States

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Jenkintown, Pennsylvania, 19046, United States

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Levittown, Pennsylvania, 19056, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Synergy Research Site

Greer, South Carolina, 29651, United States

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Moncks Corner, South Carolina, 29461, United States

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Bristol, Tennessee, 37620, United States

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Franklin, Tennessee, 37064, United States

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Synergy Research Site

Jefferson City, Tennessee, 37760, United States

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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37919, United States

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Knoxville, Tennessee, 37938, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37211, United States

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Arlington, Texas, 76012, United States

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Synergy Research Site

Austin, Texas, 78705, United States

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Synergy Research Site

Austin, Texas, 78731, United States

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Synergy Research Site

Austin, Texas, 78735, United States

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Carrollton, Texas, 75007, United States

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Synergy Research Site

Carrollton, Texas, 75010, United States

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Channelview, Texas, 77530, United States

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Dallas, Texas, 75224, United States

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Synergy Research Site

Dallas, Texas, 75231, United States

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Gonzales, Texas, 78629, United States

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Houston, Texas, 77015, United States

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Synergy Research Site

Houston, Texas, 77025, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77062, United States

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Pharr, Texas, 78577, United States

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Plano, Texas, 75024, United States

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Plano, Texas, 75075, United States

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Synergy Research Site

Plano, Texas, 75093, United States

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Synergy Research Site

Plano, Texas, 75903, United States

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Synergy Research Site

San Antonio, Texas, 78205, United States

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Synergy Research Site

San Antonio, Texas, 78215, United States

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Draper, Utah, 84020, United States

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Synergy Research Site

Newport News, Virginia, 23606, United States

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Synergy Research Site

Sterling, Virginia, 20166, United States

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Synergy Research Site

Richland, Washington, 99352, United States

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Related Publications (4)

• 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

• 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

• DeMicco M, Barrow L, Hickey B, Shailubhai K, Griffin P. Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation. Therap Adv Gastroenterol. 2017 Nov;10(11):837-851. doi: 10.1177/1756283X17734697. Epub 2017 Oct 25.

  PMID: 29147135 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

plecanatide

Condition Hierarchy (Ancestors)

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

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: April 22, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 28, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-05

Locations

US (167)