Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

NCT01919697 | Completed Phase 3 Results

• 1 other identifier: SP304203-01
• Study Type: interventional
• Target: 2,370
• Locations: 2 countries
• Sites: 220

Brief Summary

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Conditions

Chronic Idiopathic Constipation

Keywords

Plecantaide; Chronic Idiopathic Constipation; Chronic; Idiopathic; Constipation; Synergy; CIC; CIC study; CIC OLE; CIC OLE study; OLE; OLE CIC; OLE CIC3; Open label; Open label study; Long term; Long term study; Extension; Extension study

Outcome Measures

Primary Outcomes (8)

• Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

  All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.

  From first dose up to 72 weeks

• Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

  Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

  From first dose up to 72 weeks

• Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

  The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  From first dose up to 72 weeks

• Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

  The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  From first dose up to 72 weeks

• Summary of Vital Signs at >Day 364 - Body Temperature (°C)

  The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  From first dose up to 72 weeks

• Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

  The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  From first dose up to 72 weeks

• Summary of ECG Results Shift From Baseline at > Day 364

  Baseline was defined as the last non-missing value collected prior to first dose of study drug)

  From first dose up to 72 weeks

• Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

  Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

  From first dose up to 72 weeks

Secondary Outcomes (4)

• Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

  Form first dose up to 72 weeks

• Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

  From first dose up to 72 weeks

• Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

  From first dose up to 72 weeks

• Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

  From first dose up to 72 weeks

Study Arms (2)

Plecanatide 3.0 mg

EXPERIMENTAL

Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks

Drug: Plecanatide

Plecanatide 6.0 mg

EXPERIMENTAL

Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks

Drug: Plecanatide

Interventions

Plecanatide DRUG

Plecanatide 3.0 mg; Plecanatide 6.0 mg

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
• Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

You may not qualify if:

• Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
• Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• Patient has taken a protocol-prohibited drug without the appropriate washout period.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Syneos Health: collaborator

Study Sites (220)

Synergy Research Site

Birmingham, Alabama, 35242, United States

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Synergy Research Site

Dothan, Alabama, 36305, United States

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Gulf Shores, Alabama, 36542, United States

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Huntsville, Alabama, 35801, United States

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Chandler, Arizona, 85224, United States

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Phoenix, Arizona, 85018, United States

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Tempe, Arizona, 85283, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85716, 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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Artesia, California, 90701, 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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Corona, California, 92879, United States

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Encinitas, California, 92024, 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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La Mirada, California, 90638, United States

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Laguna Hills, California, 92653, 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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Mission Hills, California, 91345, United States

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North Hollywood, California, 91606, United States

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Orange, California, 92868, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95821, 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, 80904, 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, 80128, United States

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Bristol, Connecticut, 06010, 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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Brandon, Florida, 33511, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33759, United States

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Cutler Bay, Florida, 33189, 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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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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Homestead, Florida, 33030, United States

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Jupiter, Florida, 33458, United States

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Lakeland, Florida, 33805, 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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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33130, United States

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Miami, Florida, 33142, 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, 33174, United States

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Miami, Florida, 33175, United States

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Miami, Florida, 33176, United States

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Miami, Florida, 33186, 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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Orlando, Florida, 32801, United States

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Orlando, Florida, 32806, United States

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Orlando, Florida, 32807, United States

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Pembroke Pines, Florida, 33026, United States

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Port Orange, Florida, 32129, 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, 33606, United States

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Tampa, Florida, 33607, United States

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West Palm Beach, Florida, 33409, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30032, United States

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Decatur, Georgia, 30033, United States

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Oakwood, Georgia, 30566, United States

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Sandy Springs, Georgia, 30328, United States

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Savannah, Georgia, 31406, United States

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Smyrna, Georgia, 30082, United States

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Snellville, Georgia, 30078, United States

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Blackfoot, Idaho, 83221, United States

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Chicago, Illinois, 60602, United States

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Brownsburg, Indiana, 46112, 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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Owensboro, Kentucky, 42303, 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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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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Grand Island, Nebraska, 68803, 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, 89103, 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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Elizabeth, New Jersey, 07202, United States

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Lodi, New Jersey, 07644, United States

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Marlton, New Jersey, 08053, United States

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Albuquerque, New Mexico, 87108, 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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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, 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, 45224, United States

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Cincinnati, Ohio, 45246, United States

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Cleveland, Ohio, 44122, 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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Oklahoma City, Oklahoma, 73104, United States

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Levittown, Pennsylvania, 19056, United States

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Limerick, Pennsylvania, 19468, United States

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Philadelphia, Pennsylvania, 19152, United States

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Pittsburgh, Pennsylvania, 15206, 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, 29406, United States

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Columbia, South Carolina, 29203, United States

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Chattanooga, Tennessee, 37421, United States

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Franklin, Tennessee, 37064, United States

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Jackson, Tennessee, 38305, United States

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Knoxville, Tennessee, 37912, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37211, United States

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New Tazewell, Tennessee, 37825, United States

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Arlington, Texas, 76012, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78745, United States

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Channelview, Texas, 77530, 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, 77034, 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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Houston, Texas, 77099, United States

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Humble, Texas, 77338, United States

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Katy, Texas, 77450, United States

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Plano, Texas, 75093, 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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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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West Jordan, Utah, 84088, 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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Newport News, Virginia, 23606, 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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Richland, Washington, 99352, 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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Cambridge, Ontario, N1S 2M6, Canada

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Greater Sudbury, Ontario, P3A 1Y8, Canada

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Toronto, Ontario, M3J 2C5, 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 (1)

• Barish CF, Griffin P. Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study. Curr Med Res Opin. 2018 Apr;34(4):751-755. doi: 10.1080/03007995.2018.1430024. Epub 2018 Feb 2.

  PMID: 29343131 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Constipation

Interventions

plecanatide

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; 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

• Richard A Krause, MD

  ClinSearch, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (211); CA (9)