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Chronic Idiopathic ConstipationPhase 2/3NCT01429987

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

A Phase 2/3 study testing plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 121 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Idiopathic Constipation
What is being tested?
plecanatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
951 participants
Where
121 sitesUnited States
Study dates
Oct 2011to Dec 2012
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18-75, inclusive
  • Body Mass Index = 18-35 kg/m2, inclusive
  • Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
  • Less than 3 CSBMs per week at baseline and during pretreatment
  • Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
  • Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
  • Willing to maintain a stable diet during the study.
  • Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Who cannot join

  • Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
  • Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
  • Active peptic ulcer disease not adequately treated or not stable
  • History of cathartic colon, laxative, enema abuse, or ischemic colitis.
  • Fecal impaction within 3 months of screening
  • Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
  • Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
  • Major surgery within 60 days of screening.

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • Albuquerque Clinical Trials, Inc

    Albuquerque, New Mexico, 87102

  • Lovelace Scientific Resources, Inc

    Albuquerque, New Mexico, 87108

  • ACRI-Phase 1,LLC

    Anaheim, California, 92801

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Horizon Research Group, LLC

    Baton Rouge, Louisiana, 70808

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • MediSpect, LLC

    Boone, North Carolina, 28607

  • Boston Clinical Trials, Inc

    Boston, Massachusetts, 02135

  • Consultants for Clinical Research of S. Florida

    Boynton Beach, Florida, 33426

  • NY Total Medical Care

    Brooklyn, New York, 11215

  • Synergy First

    Brooklyn, New York, 11230

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Translational Research Group, INC., d/b/a Providence Clinical Research

    Burbank, California, 91505

  • Valley Medical Research

    Centerville, Ohio, 45459

  • East Valley Gastroenterology and Hepatology Associates, PC

    Chandler, Arizona, 85224

  • Clinical and Translational Research Center Hospital

    Chapel Hill, North Carolina, 27599-7600

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28210

  • Ridgeview Research

    Chaska, Minnesota, 55318

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Medex Healthcare Research, Inc.

    Chicago, Illinois, 60602

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc

    Chula Vista, California, 91910

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Consultants in Gastroenerology

    Columbia, South Carolina, 29203

  • Hometown Urgent Care

    Columbus, Ohio, 43214

  • KRK Medical Research

    Dallas, Texas, 75230

  • Research Across America

    Dallas, Texas, 75234

  • Carolina Digestive Health Associates

    Davidson, North Carolina, 28036

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Gastro Specialists Research Center, LLC

    Decatur, Georgia, 30032

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • CTL Research

    Eagle, Idaho, 83616

  • Reasearch Across America

    El Paso, Texas, 79902

  • Central Jersey Medical Research Center

    Elizabeth, New Jersey, 07202

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • NECCR Internal Medicine and Cardiology Associates, LLC

    Fall River, Massachusetts, 02720

  • Internal Medical Associates of Grand Island, PC

    Grand Island, Nebraska, 68803

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • LeBauer Research Associates, PA

    Greensboro, North Carolina, 27403

  • Medoff Medical / Vital re:Search

    Greensboro, North Carolina, 27408

  • Hometown Urgent Care

    Groveport, Ohio, 43125

  • Carolina Digestive Health Associates

    Harrisburg, North Carolina, 28075

  • Clinical Research Partners, LLC

    Henrico, Virginia, 23233

  • Associates in Gastroenterology

    Hermitage, Tennessee, 37076

  • Medical Research Unlimited, LLC

    Hialeah, Florida, 33012

  • Mid-Atlantic Medical Research Centers

    Hollywood, Maryland, 20636

  • Gastroenterology Consultants

    Houston, Texas, 77034

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77098

  • Hutchinson Clinic, P.A

    Hutchinson, Kansas, 67502

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • HCCA Clinical Research Solutions

    Jackson, Tennessee, 38305

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Jupiter Research, Inc.

    Jupiter, Florida, 33458

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • Research Across America

    Katy, Texas, 77450

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • Memorial Health System, Inc., d/b/a LaPorte Medical Group

    La Porte, Indiana, 46350

  • Midwest Center for Clinical Research

    Lee's Summit, Missouri, 64064

  • Preferred Research Partners, Inc

    Little Rock, Arkansas, 72211

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia

    Lynchburg, Virginia, 24502

  • South Jersey Gastroenterology, PA

    Marlton, New Jersey, 08053

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Miami Gastroenterology Consultants, PA

    Miami, Florida, 33156

  • Advance Medical Research Service Corp

    Miami, Florida, 33165

  • Advance Medical Research Service

    Miami, Florida, 33165

  • Florida International Research Center

    Miami, Florida, 33166

  • Columbus Clinical Services, LLC

    Miami, Florida, 33174

  • South Medical Research Group, Inc

    Miami, Florida, 33186

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Burke Primary Care

    Morgantown, North Carolina, 28655

  • St. Thomas Medical Group

    Nashville, Tennessee, 37205

  • Women Under Study, LLC

    New Orleans, Louisiana, 70115

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • National Clinical Research-Norfolk, Inc

    Norfolk, Virginia, 23502

  • Southwest Gastroenterology Assoc

    Oak Lawn, Illinois, 60453

  • Clinical Research Associates, LLC

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc.

    Omaha, Nebraska, 68114

  • Community Clinical Trials

    Orange, California, 92868

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Research Integrity

    Owensboro, Kentucky, 42303

  • Digestive Health Center

    Pasadena, Texas, 77505

  • Gold Coast Research, LLC

    Plantation, Florida, 33317

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Wake Research associates, LLC

    Raleigh, North Carolina, 27612

  • Dormir Clinical Trials, Inc

    Redlands, California, 92373

  • Inland Gastroenterology Medical Associates, Inc.

    Redlands, California, 92374

  • National Clinical Research-Richmond, Inc.

    Richmond, Virginia, 23294

  • Jeffrey Danzig

    Ridgewood, New Jersey, 07450

  • Remedica LLC

    Rochester, Michigan, 48307

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

  • Superior Research LLC

    Sacramento, California, 95825

  • Utah Clinical Trials. LLC

    Salt Lake City, Utah, 84107

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • DMI Research

    Seminole, Florida, 33777

  • Willis-Knighton Physician Network / Pinnacle Gastroenterology

    Shreveport, Louisiana, 71103

  • Memorial Health System, Inc., d/b/a Ireland Road Medical Group

    South Bend, Indiana, 46614

  • American Center for Clinical Trials

    Southfield, Michigan, 48034

  • Spring Gastroenterology PA

    Spring, Texas, 77386

  • Hometown Urgent Care and Research

    Springfield, Ohio, 45504

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Meridien Research

    Tampa, Florida, 33606

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • North American Partners in Pain Management

    Valley Stream, New York, 11580

  • Progressive Clinical Research

    Vista, California, 92083

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Paddu and Associates, LLP

    Woodside, New York, 11377

Other trials in United States

About this study

Official title: Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Read the detailed description

This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses.

Being tested
plecanatide, Placebo
Keywords
Chronic Idiopathic Constipation, Constipation, Sign and Symptoms: Digestive
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plecanatideDrug

    Also called Trulance

    Subjects receive experimental study drug for 12 weeks.

  • PlaceboOther

    Subjects receive experimental study drug for 12 weeks.

Study groups in NCT01429987
Study groupRoleWhat they receive
plecanatide 0.3 mgExperimentalSubjects receive plecanatide 0.3 mg for 12 consecutive weeks
Receives: Drug: plecanatide
plecanatide 1.0 mgExperimentalSubjects receive plecanatide 1.0 mg for 12 consecutive weeks
Receives: Drug: plecanatide
plecanatide 3.0 mgExperimentalSubjects receive plecanatide 3.0 mg for 12 consecutive weeks
Receives: Drug: plecanatide
PlaceboPlacebo comparatorSubjects receive placebo for 12 consecutive weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Responder 9/12 Weeks

    A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.

    Measured: 12-Week Treatment Period

Secondary outcomes (4)

  1. Change From Baseline in 12-week CSBM Weekly Frequency Rate

    The number of Complete Spontaneous Bowel Movements (CSBMs) per week

    Measured: 12-Week Treatment Period

  2. Change From Baseline in 12-week SBM Weekly Frequency Rate

    The number of Spontaneous Bowl Movements experienced per week.

    Measured: 12-Week Treatment Period

  3. Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period

    The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.

    1. = separate hard lumps like nuts (difficult to pass)
    2. = sausage shaped but lumpy
    3. = like a sausage but with cracks on its surface
    4. = like a sausage or snake, smooth and soft
    5. = soft blobs with clear-cut edges (passed easily)
    6. = fluffy pieces with ragged edges, a mushy stool
    7. = watery, no solid pieces (entirely liquid)

    Measured: 12-Week Treatment Period

  4. Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score

    The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

    Measured: 12-Week Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
951 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01429987
Sponsor's protocol ID
SP304-20210
Other IDs
SP-SP30420210
Status last verified
May 2019
First submitted
6 Sep 2011
Last updated
28 May 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 121 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Responder 9/12 Weeks (time frame: 12-Week Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01429987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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