Chronic Idiopathic ConstipationPhase 3NCT01982240
12-Week Study of Plecanatide for CIC (The CIC3 Study)
A Phase 3 study testing Plecanatide and Bisacodyl in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 189 sites in 2 countries.
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 and Bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,394 participants
- Where
- 189 sitesin 2 countries
- Study dates
- Nov 2013to Jun 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 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 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 MI within 60 days of screening
- Participated in a previous plecanatide clinical trial
Trial locations and contacts
189 sites in 2 countries.
189 sites in 2 countries
United States177 sites
Synergy Research Site
Albuquerque, New Mexico, 87109
Synergy Research Site
Anaheim, California, 92801
Synergy Research Site
Anaheim, California, 92804
Synergy Research Site
Anderson, South Carolina, 29621
Synergy Research Site
Athens, Georgia, 30606
Synergy Research Site
Augusta, Georgia, 30912
Synergy Research Site
Augusta, Kansas, 67010
Synergy Research Site
Austin, Texas, 78745
Synergy Research Site
Bastrop, Louisiana, 71220
Synergy Research Site
Beavercreek, Ohio, 45432
Synergy Research Site
Biloxi, Mississippi, 39531
Synergy Research Site
Birmingham, Alabama, 35242
Synergy Research Site
Boston, Massachusetts, 02131
Synergy Research Site
Boynton Beach, Florida, 33426
Synergy Research Site
Bristol, Connecticut, 06010
Synergy Research Site
Brockton, Massachusetts, 02302
Synergy Research Site
Brooklyn, New York, 11206
Synergy Research Site
Carlsbad, California, 92008
Synergy Research Site
Cary, North Carolina, 27518
Synergy Research Site
Centerville, Ohio, 45459
Synergy Research Site
Cerritos, California, 90703
Synergy Research Site
Chapel Hill, North Carolina, 27599
Synergy Research Site
Charleston, South Carolina, 28406
Synergy Research Site
Charlotte, North Carolina, 28210
Synergy Research Site
Charlotte, North Carolina, 28277
Synergy Research Site
Chattanooga, Tennessee, 37421
Synergy Research Site
Chesterfield, Michigan, 48047
Synergy Research Site
Chevy Chase, Maryland, 20815
Synergy Research Site
Christiansburg, Virginia, 24073
Synergy Research Site
Chula Vista, California, 91910
Synergy Research Site
Cincinnati, Ohio, 45246
Synergy Research Site
Clearwater, Florida, 33759
Synergy Research Site
Clive, Iowa, 50325
Synergy Research Site
Colorado Springs, Colorado, 80907
Synergy Research Site
Colorado Springs, Colorado, 80909
Synergy Research Site
Columbia, South Carolina, 29204
Synergy Research Site
Dallas, Texas, 75230
Synergy Research Site
Dallas, Texas, 75234
Synergy Research Site
Danbury, Connecticut, 06810
Synergy Research Site
Decatur, Georgia, 30032
Synergy Research Site
Decatur, Georgia, 30033
Synergy Research Site
DeLand, Florida, 32720
Synergy Research Site
Denver, Colorado, 80218
Synergy Research Site
Denver, Colorado, 80220
Synergy Research Site
Denver, Colorado, 80246
Synergy Research Site
Dothan, Alabama, 36305
Synergy Research Site
El Cajon, California, 92020
Synergy Research Site
Encinitas, California, 92024
Synergy Research Site
Encino, California, 91436
Synergy Research Site
Evanston, Illinois, 60201
Synergy Research Site
Fargo, North Dakota, 58103
Synergy Research Site
Flint, Michigan, 48504
Synergy Research Site
Fort Lauderdale, Florida, 33306
Synergy Research Site
Fort Lauderdale, Florida, 33308
Synergy Research Site
Fountain Valley, California, 92708
Synergy Research Site
Fresno, California, 93726
Synergy Research Site
Great Neck, New York, 11023
Synergy Research Site
Greensboro, North Carolina, 27403
Synergy Research Site
Gulf Shores, Alabama, 36542
Synergy Research Site
Hawaiian Gardens, California, 90716
Synergy Research Site
Henderson, Nevada, 89014
Synergy Research Site
Henrico, Virginia, 23233
Synergy Research Site
Hialeah, Florida, 33012
Synergy Research Site
Hilliard, Ohio, 43026
Synergy Research Site
Hot Springs, Arkansas, 71913
Synergy Research Site
Houston, Texas, 77043
Synergy Research Site
Houston, Texas, 77062
Synergy Research Site
Houston, Texas, 77070
Synergy Research Site
Houston, Texas, 77090
Synergy Research Site
Huber Heights, Ohio, 45424
Synergy Research Site
Huntsville, Alabama, 35801
Synergy Research Site
Jackson, Mississippi, 39202
Synergy Research Site
Jackson, Tennessee, 38305
Synergy Research Site
Johns Creek, Georgia, 30097
Synergy Research Site
Jupiter, Florida, 33458
Synergy Research Site
Killeen, Texas, 76543
Synergy Research Site
Kinston, North Carolina, 28501
Synergy Research Site
Lakeland, Florida, 33805
Synergy Research Site
Lancaster, California, 93534
Synergy Research Site
Las Vegas, Nevada, 89119
Synergy Research Site
Las Vegas, Nevada, 89121
Synergy Research Site
Lebanon, New Hampshire, 03756
Synergy Research Site
Lexington, Kentucky, 40503
Synergy Research Site
Lexington, Kentucky, 40504
Synergy Research Site
Limerick, Pennsylvania, 19468
Synergy Research Site
Little Rock, Arkansas, 72211
Synergy Research Site
Littleton, Colorado, 80120
Synergy Research Site
Lodi, New Jersey, 07644
Synergy Research Site
Logan, Utah, 84341
Synergy Research Site
Long Beach, California, 90806
Synergy Research Site
Los Angeles, California, 90015
Synergy Research Site
Los Angeles, California, 90045
Synergy Research Site
Los Angeles, California, 90067
Synergy Research Site
Lynchburg, Virginia, 24502
Synergy Research Site
Lynn Haven, Florida, 32444
Synergy Research Site
Marrero, Louisiana, 70072
Synergy Research Site
Maumee, Ohio, 43537
Synergy Research Site
Mentor, Ohio, 44060
Synergy Research Site
Mesa, Arizona, 85206
Synergy Research Site
Metairie, Louisiana, 70006
Synergy Research Site
Miami, Florida, 33130
Synergy Research Site
Miami, Florida, 33165
Synergy Research Site
Miami, Florida, 33173
Synergy Research Site
Miami, Florida, 33174
Synergy Research Site
Miami, Florida, 33185
Synergy Research Site
Miami, Florida, 33186
Synergy Research Site
Mission Hills, California, 91345
Synergy Research Site
Mobile, Alabama, 36695
Synergy Research Site
Murrieta, California, 92562
Synergy Research Site
Nashville, Tennessee, 37205
Synergy Research Site
New Bedford, Massachusetts, 02740
Synergy Research Site
New Orleans, Louisiana, 70115
Synergy Research Site
New Orleans, Louisiana, 70119
Synergy Research Site
New Tazewell, Tennessee, 37825
Synergy Research Site
Newton, Kansas, 67114
Synergy Research Site
Norfolk, Virginia, 23502
Synergy Research Site
Norfolk, Virginia, 23507
Synergy Research Site
Norman, Oklahoma, 73071
Synergy Research Site
North Hollywood, California, 91606
Synergy Research Site
North Little Rock, Arkansas, 72117
Synergy Research Site
North Massapequa, New York, 11758
Synergy Research Site
Oakwood, Georgia, 30566
Synergy Research Site
Oakwood, Ohio, 45419
Synergy Research Site
Ocean City, New Jersey, 07712
Synergy Research Site
Oceanside, California, 92054
Synergy Research Site
Oklahoma City, Oklahoma, 73102
Synergy Research Site
Omaha, Nebraska, 68114
Synergy Research Site
Orlando, Florida, 32803
Synergy Research Site
Orlando, Florida, 32806
Synergy Research Site
Oxnard, California, 93030
Synergy Research Site
Pasadena, California, 91105
Synergy Research Site
Philadelphia, Pennsylvania, 19152
Synergy Research Site
Phoenix, Arizona, 85018
Synergy Research Site
Phoenix, Arizona, 85023
Synergy Research Site
Plano, Texas, 75093
Synergy Research Site
Port Orange, Florida, 32129
Synergy Research Site
Poway, California, 92064
Synergy Research Site
Raleigh, North Carolina, 27612
Synergy Research Site
Reno, Nevada, 89511
Synergy Research Site
Richmond, Virginia, 23294
Synergy Research Site
Rochester, Michigan, 48307
Synergy Research Site
Sacramento, California, 95816
Synergy Research Site
Saginaw, Michigan, 48604
Synergy Research Site
Salt Lake City, Utah, 84124
Synergy Research Site
San Angelo, Texas, 76904
Synergy Research Site
San Antonio, Texas, 78209
Synergy Research Site
San Antonio, Texas, 78258
Synergy Research Site
San Diego, California, 92101
Synergy Research Site
San Diego, California, 92103
Synergy Research Site
San Diego, California, 92108
Synergy Research Site
San Diego, California, 92114
Synergy Research Site
Savannah, Georgia, 31406
Synergy Research Site
Seattle, Washington, 98105
Synergy Research Site
Shawnee Mission, Kansas, 66218
Synergy Research Site
Shreveport, Louisiana, 71103
Synergy Research Site
Smithfield, Pennsylvania, 15478
Synergy Research Site
Smyrna, Georgia, 30082
Synergy Research Site
Southfield, Michigan, 48034
Synergy Research Site
St Louis, Missouri, 63128
Synergy Research Site
St. George, Utah, 84790
Synergy Research Site
Stow, Ohio, 44224
Synergy Research Site
Sugar Land, Texas, 77479
Synergy Research Site
Tacoma, Washington, 98405
Synergy Research Site
Tampa, Florida, 33604
Synergy Research Site
Tampa, Florida, 33606
Synergy Research Site
Tampa, Florida, 33617
Synergy Research Site
Tempe, Arizona, 85283
Synergy Research Site
Thousand Oaks, California, 91360
Synergy Research Site
Tucson, Arizona, 85712
Synergy Research Site
Virginia Beach, Virginia, 23455
Synergy Research Site
Waterbury, Connecticut, 06708
Synergy Research Site
Wauwatosa, Wisconsin, 53226
Synergy Research Site
Wichita, Kansas, 67205
Synergy Research Site
Wichita, Kansas, 67207
Synergy Research Site
Wilmington, North Carolina, 28401
Synergy Research Site
Winston-Salem, North Carolina, 27103
Synergy Research Site
Yardley, Pennsylvania, 19067
Canada12 sites
Synergy Research Site
Brampton, Ontario, L6T 0G1
Synergy Research Site
Bridgewater, Nova Scotia, B4V 3N2
Synergy Research Site
Cambridge, Ontario, N1S 2M6
Synergy Research Site
Greater Sudbury, Ontario, P3E 1H5
Synergy Research Site
Kelowna, British Columbia, V1Y 1Z9
Synergy Research Site
London, Ontario, N5Y 5K7
Synergy Research Site
Mirabel, Quebec, J7J 2K8
Synergy Research Site
Oshawa, Ontario, L1H 1B9
Synergy Research Site
Pointe-Claire, Quebec, H9R 4S3
Synergy Research Site
Saint Romuald, Quebec, G6W 5M6
Synergy Research Site
Toronto, Ontario, M3H 5S4
Synergy Research Site
Toronto, Ontario, M9W 4L6
About this study
Official title: A 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 CIC3 Study)
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 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 (US) and Canada. 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.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- Plecanatide, Placebo, Bisacodyl
- 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
Also called Trulance
Plecanatide tablets QD for 12 weeks
PlaceboDrug
Also called Trulance placebo
Matching placebo tablets QD for 12 weeks
BisacodylDrug
Also called Dulcolax
Rescue medication
| Study group | Role | What they receive |
|---|---|---|
| Plecanatide 3.0 mg | Active comparator | Plecanatide tablets 3.0 mg QD for 12 weeks Receives: Drug: Plecanatide |
| Plecanatide 6.0 mg | Active comparator | Plecanatide tablets 6.0 mg QD for 12 weeks Receives: Drug: Plecanatide |
| Placebo | Placebo comparator | Matching placebo tablets QD for 12 weeks Receives: Drug: Placebo |
| Bisacodyl | Other | Rescue medication Receives: Drug: Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Durable Overall CSBM Responders , Mean Replacement Approach
A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included 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)
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.
Measured: 12-Week Treatment Period
Change From Baseline in SBM (SBMs/Week) Over 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 assessed. 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 in the BM and Symptom Diary.
Measured: 12-Week Treatment Period
Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
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.
- = separate hard lumps like nuts (difficult to pass)
- = sausage shaped but lumpy
- = like a sausage but with cracks on its surface
- = like a sausage or snake, smooth and soft
- = soft blobs with clear-cut edges (passed easily)
- = fluffy pieces with ragged edges, a mushy stool
- = watery, no solid pieces (entirely liquid)
Measured: 12-Week Treatment Period
Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach
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: 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.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Beth Layton, Study director, Synergy Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982240
- Sponsor's protocol ID
- SP304203-00
- Status last verified
- Dec 2019
- First submitted
- 5 Nov 2013
- Last updated
- 26 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 37332239Rao SSC, Laitman AP, Miner PB Jr. Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00598. doi: 10.14309/ctg.0000000000000598.
PubMed 37162147Moshiree 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 35086735Menees 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 32660770Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH. A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation. Am J Gastroenterol. 2017 Apr;112(4):613-621. doi: 10.1038/ajg.2016.611. Epub 2017 Feb 7.
PubMed 28169285
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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 CIC3 Study)
- ClinicalTrials.gov ID
- NCT01982240
- Acronym / sponsor ID
- SP304203-00
- Conditions
- Chronic Idiopathic Constipation
- Keywords
- CIC, Constipation, Chronic Constipation, Synergy, Plecanatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,394 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Detailed description
This is a 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 (US) and Canada. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plecanatide 3.0 mg | Active comparator | Drug: PlecanatidePlecanatide tablets 3.0 mg QD for 12 weeks |
| Plecanatide 6.0 mg | Active comparator | Drug: PlecanatidePlecanatide tablets 6.0 mg QD for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets QD for 12 weeks |
| Bisacodyl | Other | Drug: BisacodylRescue medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 AGA colon cancer screening guidelines (5 years), with no clinically significant findings
- Willing to maintain a stable diet during the study
Key exclusion criteria (8 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlecanatideAlso: TrulancePlecanatide tablets QD for 12 weeks | Drug | Plecanatide 3.0 mg, Plecanatide 6.0 mg |
| PlaceboAlso: Trulance placeboMatching placebo tablets QD for 12 weeks | Drug | Placebo |
| BisacodylAlso: DulcolaxRescue medication | Drug | Bisacodyl |
Primary outcome
Number of Durable Overall CSBM Responders , Mean Replacement Approach
Time frame: 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, included 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.
4 secondary outcomes
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
Time frame: 12-Week Treatment Period
Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
Time frame: 12-Week Treatment Period
Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
Time frame: 12-Week Treatment Period
Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach
Time frame: 12-Week Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37332239Cash 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.
- Derived from this study: PubMed 37162147Rao SSC, Laitman AP, Miner PB Jr. Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00598. doi: 10.14309/ctg.0000000000000598.
- Derived from this study: PubMed 35086735Moshiree 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.
- Derived from this study: PubMed 32660770Menees 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.
- Derived from this study: PubMed 28169285Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH. A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation. Am J Gastroenterol. 2017 Apr;112(4):613-621. doi: 10.1038/ajg.2016.611. Epub 2017 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Beth Layton study director
Synergy Pharmaceuticals Inc.
189 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plecanatide and Bisacodyl in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 189 sites in 2 countries.
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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 189 sites in United States, Canada. 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 21 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 NCT01982240, which also lists 5 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 26 Dec 2019.