Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

NCT02493452 | Completed Phase 3 Results

• 1 other identifier: SP304203-05
• Study Type: interventional
• Target: 1,135
• Locations: 1 country
• Sites: 191

Brief Summary

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (3)

• Number of Overall Responders - ITT Population

  An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.

  12 weeks

• Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks

  An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.

  12 Weeks

• Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks

  A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.

  12 Weeks

Secondary Outcomes (6)

• Number of Sustained Efficacy Responders

  12 Weeks

• Change From Baseline in Stool Consistency

  Baseline and 12-Week

• Change From Baseline in Straining

  Baseline and 12-Week

• Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement

  Baseline and 12-Week

• Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication

  Up to 24 hours after the first dose of study drug

Study Arms (3)

3.0 mg plecanatide

ACTIVE COMPARATOR

Plecanatide 3.0 mg dosed daily for 12 weeks

Drug: Plecanatide

6.0 mg plecanatide

ACTIVE COMPARATOR

Plecanatide 6.0 mg dosed daily for 12 weeks

Drug: Plecanatide

Matching placebo

ACTIVE COMPARATOR

Placebo dosed daily for 12 weeks

Drug: Placebo

Interventions

Plecanatide DRUG

3.0 mg plecanatide; 6.0 mg plecanatide

Placebo DRUG

Matching placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

You may not qualify if:

• Refusal or inability to sign informed consent for the trial
• Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
• BMI ≥ 40 or \< 18
• Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
• Women who are pregnant or lactating
• Diagnosis of IBS-D or IBS-M
• Organic or obstructive disease of the small or large intestine
• Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
• Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
• Unstable medical illness
• Bilirubin \> 3X ULN in the absence of a conjugation defect
• Any laboratory value \> 3X ULN unless discussed and approved by the study Medical Monitor

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (191)

Synergy Research Site

Birmingham, Alabama, 35209, United States

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Synergy Research Site

Birmingham, Alabama, 35216, United States

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Synergy Research Site

Guntersville, Alabama, 35976, United States

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Huntsville, Alabama, 35801, United States

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Saraland, Alabama, 36571, United States

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Glendale, Arizona, 85301, United States

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Phoenix, Arizona, 85018, United States

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Surprise, Arizona, 85374, United States

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Tucson, Arizona, 85745, United States

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Conway, Arkansas, 72034, United States

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Little Rock, Arkansas, 72205, United States

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Canoga Park, California, 91303, United States

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Carmichael, California, 95608, United States

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Chino, California, 91710, 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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Encino, California, 91436, United States

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Foothill Ranch, California, 92610, United States

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Garden Grove, California, 92844, United States

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Huntington Beach, California, 92647, United States

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Irvine, California, 92614, United States

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Lomita, California, 90717, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90045, United States

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Mission Hills, California, 91345, United States

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Montclair, California, 91763, United States

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Northridge, California, 91324, United States

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Norwalk, California, 90650, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Orangevale, California, 95662, United States

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Placentia, California, 92870, United States

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Riverside, California, 92501, United States

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San Diego, California, 92103, United States

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San Marino, California, 91108, United States

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Santa Ana, California, United States

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Sherman Oaks, California, 91403, United States

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Colorado Springs, Colorado, 80920, United States

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Denver, Colorado, 80246, United States

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Hamden, Connecticut, 06517, United States

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Atlantis, Florida, 33462, United States

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Boca Raton, Florida, 33428, United States

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Bradenton, Florida, 34201, 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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Cutler Bay, Florida, 33189, United States

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Fort Lauderdale, Florida, 33306, United States

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Fort Lauderdale, Florida, 33312, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33013, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32256, United States

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Lauderdale Lakes, Florida, 33319, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33016, United States

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Miami, Florida, 33032, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, 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, 33176, United States

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Miami, Florida, 33183, United States

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Miami Lakes, Florida, 33016, United States

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Miami Lakes, Florida, 33173, United States

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Miami Springs, Florida, 33166, United States

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Naples, Florida, 34102, United States

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North Miami Beach, Florida, 33162, United States

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Orange Park, Florida, 32073, United States

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Orlando, Florida, 32806, United States

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Orlando, Florida, 32807, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33024, United States

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Pinellas Park, Florida, 33782, United States

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Port Orange, Florida, 32127, United States

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Tamarac, Florida, 33319, United States

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Tampa, Florida, 33613, United States

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Tampa, Florida, 33634, United States

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Williston, Florida, 32696, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Lilburn, Georgia, 30047, United States

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Marietta, Georgia, 30060, 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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Meridian, Idaho, 83646, United States

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Blue Island, Illinois, 60406, United States

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Chicago, Illinois, 60602, United States

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Evanston, Illinois, 60201, United States

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Hoffman Estates, Illinois, 60169, United States

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Morton, Illinois, 61550, 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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Brownsburg, Indiana, 46112, United States

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Indianapolis, Indiana, 46237, United States

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Wichita, Kansas, 67203, United States

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Madisonville, Kentucky, 42431, United States

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Owensboro, Kentucky, 42303, United States

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Marrero, Louisiana, 70072, United States

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Annapolis, Maryland, 21401, United States

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Catonsville, Maryland, 21228, United States

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Oxon Hill, Maryland, 20745, United States

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Towson, Maryland, 21204, United States

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Marlborough, Massachusetts, 01752, United States

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Quincy, Massachusetts, 02169, United States

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Kalamazoo, Michigan, 49009, United States

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Port Gibson, Mississippi, 39150, United States

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Chesterfield, Missouri, 63005, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Missoula, Montana, 59808, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119, United States

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Blackwood, New Jersey, 08012, United States

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Egg Harbor, New Jersey, 08234, United States

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Vineland, New Jersey, 08360, United States

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Albuquerque, New Mexico, 87109, United States

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Hopewell Junction, New York, 12533, United States

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Kew Gardens, New York, 11415, United States

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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, United States

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Chapel Hill, North Carolina, 27514, United States

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Fayetteville, North Carolina, 28304, United States

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High Point, North Carolina, 27262, United States

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Jacksonville, North Carolina, 28546, United States

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Raleigh, North Carolina, 27609, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45249, United States

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Columbus, Ohio, 43214, United States

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Dayton, Ohio, 45419, United States

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Dayton, Ohio, 45439, United States

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Franklin, Ohio, 45005, United States

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Kettering, Ohio, 45429, United States

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Mentor, Ohio, 44060, United States

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Middleburg Heights, Ohio, 44130, United States

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Wadsworth, Ohio, 44203, United States

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Oklahoma City, Oklahoma, 73104, United States

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Doylestown, Pennsylvania, 18901, United States

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Lansdale, Pennsylvania, 19446, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19140, United States

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Anderson, South Carolina, 29621, United States

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Greer, South Carolina, 29651, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Fayetteville, Tennessee, 37334, United States

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Franklin, Tennessee, 37067, United States

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Hermitage, Tennessee, 37076, United States

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Jackson, Tennessee, 38305, United States

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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37909, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78758, United States

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Baytown, Texas, 77521, United States

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Beaumont, Texas, 77701, United States

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Channelview, Texas, 77530, United States

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Dallas, Texas, 75224, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75254, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77081, United States

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Humble, Texas, 77338, United States

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Lampasas, Texas, 76550, United States

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McKinney, Texas, 75070, United States

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Missouri City, Texas, 77459, United States

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Plano, Texas, 75024, United States

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Plano, Texas, 75075, United States

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Port Arthur, Texas, 77640, United States

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San Antonio, Texas, 78209, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77478, United States

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Orem, Utah, 84058, United States

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West Valley City, Utah, 84120, United States

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Chesapeake, Virginia, 23320, United States

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Fairfax, Virginia, 22031, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23220, United States

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Richmond, Virginia, 23235, United States

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Spokane, Washington, 99202, United States

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Vancouver, Washington, 98664, United States

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Kingwood, West Virginia, 26537, United States

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La Crosse, Wisconsin, 54601, United States

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Related Publications (3)

• Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10.

  PMID: 41214272 DERIVED

• 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

• 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

MeSH Terms

Interventions

plecanatide

Results Point of Contact

• Title: VP Regulatory Affairs & Clinical QA
• Organization: Synergy Pharmaceuticals Inc.

ejaeger@synergypharma.com

646-675-7283

Study Officials

• Paul F.C. Eng, PhD

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (191)