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Chronic Idiopathic ConstipationPhase 3CICNCT02122471

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

A Phase 3 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 167 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

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Idiopathic Constipation
What is being tested?
Plecanatide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,410 participants
Where
167 sitesUnited States
Study dates
Apr 2014to Jul 2015
Phase
Phase 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

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 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

Trial locations and contacts

167 sites in 1 country.

167 sites in 1 country

United States167 sites

  • Synergy Research Site

    Albuquerque, New Mexico, 87102

  • Synergy Research Site

    Albuquerque, New Mexico, 87109

  • Synergy Research Site

    Anaheim, California, 92801

  • Synergy Research Site

    Anniston, Alabama, 36207

  • Synergy Research Site

    Arlington, Texas, 76012

  • Synergy Research Site

    Artesia, California, 90701

  • Synergy Research Site

    Atlanta, Georgia, 30342

  • Synergy Research Site

    Austin, Texas, 78705

  • Synergy Research Site

    Austin, Texas, 78731

  • Synergy Research Site

    Austin, Texas, 78735

  • Synergy Research Site

    Aventura, Florida, 33180

  • Synergy Research Site

    Blackfoot, Idaho, 83221

  • Synergy Research Site

    Blackwood, New Jersey, 08012

  • Synergy Research Site

    Boise, Idaho, 83709

  • Synergy Research Site

    Boynton Beach, Florida, 33472

  • Synergy Research Site

    Bradenton, Florida, 34208

  • Synergy Research Site

    Brandon, Florida, 33511

  • Synergy Research Site

    Bristol, Tennessee, 37620

  • Synergy Research Site

    Brooksville, Florida, 34601

  • Synergy Research Site

    Buckley, Michigan, 49620

  • Synergy Research Site

    Carmichael, California, 95608

  • Synergy Research Site

    Carrollton, Texas, 75007

  • Synergy Research Site

    Carrollton, Texas, 75010

  • Synergy Research Site

    Cary, North Carolina, 27518

  • Synergy Research Site

    Chandler, Arizona, 85224

  • Synergy Research Site

    Channelview, Texas, 77530

  • Synergy Research Site

    Chicago, Illinois, 60602

  • Synergy Research Site

    Cincinnati, Ohio, 45224

  • Synergy Research Site

    Clearwater, Florida, 33756

  • Synergy Research Site

    Cleveland, Ohio, 44122

  • Synergy Research Site

    Columbia, Maryland, 21045

  • Synergy Research Site

    Columbus, Ohio, 43214

  • Synergy Research Site

    Concord, North Carolina, 28025

  • Synergy Research Site

    Corona, California, 92879

  • Synergy Research Site

    Dallas, Texas, 75224

  • Synergy Research Site

    Dallas, Texas, 75231

  • Synergy Research Site

    DeLand, Florida, 32720

  • Synergy Research Site

    Denver, Colorado, 80209

  • Synergy Research Site

    Draper, Utah, 84020

  • Synergy Research Site

    Elmsford, New York, 10523

  • Synergy Research Site

    Encino, California, 91436

  • Synergy Research Site

    Evansville, Indiana, 47714

  • Synergy Research Site

    Fort Lauderdale, Florida, 33312

  • Synergy Research Site

    Franklin, Tennessee, 37064

  • Synergy Research Site

    Gainesville, Florida, 32607

  • Synergy Research Site

    Garden Grove, California, 92843

  • Synergy Research Site

    Garden Grove, California, 92844

  • Synergy Research Site

    Glendale, California, 91204

  • Synergy Research Site

    Gonzales, Texas, 78629

  • Synergy Research Site

    Goodyear, Arizona, 85395

  • Synergy Research Site

    Greer, South Carolina, 29651

  • Synergy Research Site

    Hialeah, Florida, 33012

  • Synergy Research Site

    Hialeah, Florida, 33013

  • Synergy Research Site

    Hialeah, Florida, 33016

  • Synergy Research Site

    Hialeah, Florida, 33106

  • Synergy Research Site

    Hickory, North Carolina, 28601

  • Synergy Research Site

    Hickory, North Carolina, 28602

  • Synergy Research Site

    High Point, North Carolina, 27262

  • Synergy Research Site

    Hollywood, Florida, 33024

  • Synergy Research Site

    Homestead, Florida, 33030

  • Synergy Research Site

    Houston, Texas, 77015

  • Synergy Research Site

    Houston, Texas, 77025

  • Synergy Research Site

    Houston, Texas, 77054

  • Synergy Research Site

    Houston, Texas, 77062

  • Synergy Research Site

    Huntsville, Alabama, 35801

  • Synergy Research Site

    Jacksonville, Florida, 32256

  • Synergy Research Site

    Jacksonville, Florida, 32277

  • Synergy Research Site

    Jefferson City, Tennessee, 37760

  • Synergy Research Site

    Jenkintown, Pennsylvania, 19046

  • Synergy Research Site

    Kettering, Ohio, 45429

  • Synergy Research Site

    Kingsport, Tennessee, 37660

  • Synergy Research Site

    Knoxville, Tennessee, 37919

  • Synergy Research Site

    Knoxville, Tennessee, 37938

  • Synergy Research Site

    La Mirada, California, 90638

  • Synergy Research Site

    Laguna Hills, California, 92653

  • Synergy Research Site

    Las Vegas, Nevada, 89103

  • Synergy Research Site

    Las Vegas, Nevada, 89106

  • Synergy Research Site

    Levittown, Pennsylvania, 19056

  • Synergy Research Site

    Littleton, Colorado, 80128

  • Synergy Research Site

    Los Angeles, California, 90017

  • Synergy Research Site

    Los Angeles, California, 90036

  • Synergy Research Site

    Madisonville, Kentucky, 42431

  • Synergy Research Site

    Memphis, Tennessee, 38119

  • Synergy Research Site

    Miami, Florida, 33014

  • Synergy Research Site

    Miami, Florida, 33015

  • Synergy Research Site

    Miami, Florida, 33032

  • Synergy Research Site

    Miami, Florida, 33122

  • Synergy Research Site

    Miami, Florida, 33125

  • Synergy Research Site

    Miami, Florida, 33126

  • Synergy Research Site

    Miami, Florida, 33142

  • Synergy Research Site

    Miami, Florida, 33144

  • Synergy Research Site

    Miami, Florida, 33155

  • Synergy Research Site

    Miami, Florida, 33157

  • Synergy Research Site

    Miami, Florida, 33165

  • Synergy Research Site

    Miami, Florida, 33173

  • Synergy Research Site

    Miami, Florida, 33175

  • Synergy Research Site

    Miami, Florida, 33176

  • Synergy Research Site

    Miami, Florida, 33185

  • Synergy Research Site

    Miami Lakes, Florida, 33016

  • Synergy Research Site

    Miami Springs, Florida, 33166

  • Synergy Research Site

    Middleburg Heights, Ohio, 44130

  • Synergy Research Site

    Moncks Corner, South Carolina, 29461

  • Synergy Research Site

    Monroe, Louisiana, 71201

  • Synergy Research Site

    Nashville, Tennessee, 37211

  • Synergy Research Site

    New Hyde Park, New York, 11040

  • Synergy Research Site

    New Port Richey, Florida, 34653

  • Synergy Research Site

    New York, New York, 10016

  • Synergy Research Site

    New York, New York, 10018

  • Synergy Research Site

    Newington, New Hampshire, 03801

  • Synergy Research Site

    Newport Beach, California, 92663

  • Synergy Research Site

    Newport News, Virginia, 23606

  • Synergy Research Site

    North Miami Beach, Florida, 33162

  • Synergy Research Site

    Oak Lawn, Illinois, 60453

  • Synergy Research Site

    Oceanside, California, 92056

  • Synergy Research Site

    Oklahoma City, Oklahoma, 73103

  • Synergy Research Site

    Oklahoma City, Oklahoma, 73104

  • Synergy Research Site

    Omaha, Nebraska, 68114

  • Synergy Research Site

    Orange, California, 92868

  • Synergy Research Site

    Orlando, Florida, 32806

  • Synergy Research Site

    Orlando, Florida, 32807

  • Synergy Research Site

    Ormond Beach, Florida, 32174

  • Synergy Research Site

    Owensboro, Kentucky, 42303

  • Synergy Research Site

    Pembroke Pines, Florida, 33026

  • Synergy Research Site

    Pembroke Pines, Florida, 33028

  • Synergy Research Site

    Pharr, Texas, 78577

  • Synergy Research Site

    Pittsburgh, Pennsylvania, 15206

  • Synergy Research Site

    Plano, Texas, 75024

  • Synergy Research Site

    Plano, Texas, 75075

  • Synergy Research Site

    Plano, Texas, 75093

  • Synergy Research Site

    Plano, Texas, 75903

  • Synergy Research Site

    Plant City, Florida, 33563

  • Synergy Research Site

    Plantation, Florida, 33324

  • Synergy Research Site

    Raleigh, North Carolina, 27609

  • Synergy Research Site

    Richland, Washington, 99352

  • Synergy Research Site

    Sacramento, California, 95821

  • Synergy Research Site

    Sacramento, California, 95831

  • Synergy Research Site

    Saint Cloud, Florida, 34769

  • Synergy Research Site

    San Antonio, Texas, 78205

  • Synergy Research Site

    San Antonio, Texas, 78215

  • Synergy Research Site

    San Bernardino, California, 92408

  • Synergy Research Site

    San Diego, California, 92103

  • Synergy Research Site

    Sarasota, Florida, 34242

  • Synergy Research Site

    Savannah, Georgia, 31406

  • Synergy Research Site

    Schaumburg, Illinois, 60194

  • Synergy Research Site

    Seminole, Florida, 33777

  • Synergy Research Site

    Shreveport, Louisiana, 71105

  • Synergy Research Site

    Snellville, Georgia, 30078

  • Synergy Research Site

    St Louis, Missouri, 63141

  • Synergy Research Site

    St. Petersburg, Florida, 33709

  • Synergy Research Site

    Stamford, Connecticut, 06905

  • Synergy Research Site

    Stateline, Nevada, 89449

  • Synergy Research Site

    Sterling, Virginia, 20166

  • Synergy Research Site

    Sylvania, Ohio, 43560

  • Synergy Research Site

    Tamarac, Florida, 33319

  • Synergy Research Site

    Tampa, Florida, 33607

  • Synergy Research Site

    Tampa, Florida, 33614

  • Synergy Research Site

    Tucson, Arizona, 85704

  • Synergy Research Site

    Tucson, Arizona, 85710

  • Synergy Research Site

    Tucson, Arizona, 85712

  • Synergy Research Site

    Tucson, Arizona, 85715

  • Synergy Research Site

    Tucson, Arizona, 85745

  • Synergy Research Site

    Upland, California, 91786

  • Synergy Research Site

    Upper Saint Clair, Pennsylvania, 15241

  • Synergy Research Site

    Ventura, California, 93003

  • Synergy Research Site

    Wadsworth, Ohio, 44203

  • Synergy Research Site

    Watertown, Massachusetts, 02472

  • Synergy Research Site

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation

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

Read the detailed description

This is a national, randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Being tested
Plecanatide, Placebo
Keywords
CIC, Constipation, Chronic Constipation, Synergy, Plecanatide
Medical subject headings
Constipation

What participants receive

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

  • PlecanatideDrug

  • PlaceboDrug

Study groups in NCT02122471
Study groupRoleWhat they receive
Plecanatide 3.0 mgExperimentalPlecanatide tablets 3.0 mg QD for 12 weeks
Receives: Drug: Plecanatide
PlaceboPlacebo comparatorMatching placebo tablets QD for 12 weeks
Receives: Drug: Placebo
Plecanatide 6.0 mgExperimentalPlecanatide tablets 6.0 mg QD for 12 weeks
Receives: Drug: Plecanatide

What is being measured

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

  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.

    Measured: 12-Week Treatment Period

Secondary outcomes (4)

  1. Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach

    The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. 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.

    Measured: Baseline and 12 weeks

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

    The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was analyzed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period.

    Measured: Baseline and 12 weeks

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

    The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary.

    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: Baseline and 12 weeks

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

    The change from baseline in the straining score over the 12-week Treatment Period was analyzed. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

    Measured: Baseline and 12 weeks

Timeline

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

  1. First posted24 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2015
  4. Study completionJul 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02122471
Sponsor's protocol ID
SP304203-03
Acronym
CIC
Status last verified
May 2019
First submitted
22 Apr 2014
Last updated
28 May 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 37332239

  • 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.

    PubMed 35086735

  • 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.

    PubMed 32660770

  • 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. Ther Adv Gastroenterol. 2017 Nov;10(11):837-851. doi: 10.1177/1756283X17734697. Epub 2017 Oct 25.

    PubMed 29147135

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 167 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 4 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 167 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 phase mean?

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 14 Mar 2019). 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?

Number of Durable Overall CSBM Responders, Mean Replacement Approach (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 NCT02122471, which also lists 4 linked publications.

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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