Irritable Bowel Syndrome Characterized by ConstipationPhase 2CIBSNCT01722318
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
A Phase 2 study testing Plecanatide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Bausch Health Americas, Inc. at 99 sites in United States.
Trial summary
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome Characterized by 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
- 428 participants
- Where
- 99 sitesUnited States
- Study dates
- Nov 2012to Oct 2014
- Phase
- Phase 2
- 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 irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
- Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
- Hard or lumpy stools ≥ 25 % of defecations
- Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
Show all 9Show fewer
- 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 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 period
- Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
- 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: 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
99 sites in 1 country.
99 sites in 1 country
United States99 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Advanced Rx Clinical Research, Inc.
Artesia, California, 90701
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Georgia Regents University
Augusta, Georgia, 30912
Heartland Research Associates, LLC
Augusta, Kansas, 67010
Austin Center for Clinical Research
Austin, Texas, 78756
DCT-AACT, LLC dba Discovery Clinical Trials
Austin, Texas, 78758
Delta Research Partners, LLC
Bastrop, Louisiana, 71220
Montana Health Research Institute, Inc.
Billings, Montana, 59102
The Center for Clinical Trials
Biloxi, Mississippi, 39531
Cahaba Research
Birmingham, Alabama, 35242
MediSpect Medical Research, LLC
Boone, North Carolina, 28607
Boston Clinical Trials
Boston, Massachusetts, 02131
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426
Clinical Trials of North Carolina, LLC
Cary, North Carolina, 27518
Carolina Digestive Health Associates
Charlotte, North Carolina, 28210
On Site Clinical, LLC
Charlotte, North Carolina, 28277
Ridgeview Research
Chaska, Minnesota, 55318
Chattanooga Medical Research LLC
Chattanooga, Tennessee, 37404
ClinSearch, LLC
Chattanooga, Tennessee, 37421
IHA Chelsea Family & Internal Medicine
Chelsea, Michigan, 48118
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Medex Healthcare Research, Inc
Chicago, Illinois, 60602
New River Valley Research Institute
Christiansburg, Virginia, 24073
GW Research, Inc.
Chula Vista, California, 91910
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907
Consultants in Gastroenterology
Columbia, South Carolina, 29203
Hometown Urgent Care and Occupational Health
Columbus, Ohio, 43214
Carolina Digestive Health Associates
Davidson, North Carolina, 28036
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
CTL Research
Eagle, Idaho, 83616
Texas Tech Medical Center
El Paso, Texas, 79905
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
Franklin Gastroenterology, PLLC
Franklin, Tennessee, 37067
SC Clinical Research, Inc.
Garden Grove, California, 92844
Memphis Gastroenterology Group, PC
Germantown, Tennessee, 38138
Arrowhead Family Health Center PC dba Arrowhead Health Centers
Glendale, Arizona, 85306
Advanced Research Associates, LLC
Glendale, Arizona, 85308
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, 68803
LeBauer Research Associates, P.A.
Greensboro, North Carolina, 27403
Medoff Medical / Vital re:Search
Greensboro, North Carolina, 27408
Gastroenterology Research of New Orleans
Hammond, Louisiana, 70403
Associates in Gastroenterology
Hermitage, Tennessee, 37076
Medical Research Unlimited, LLC
Hialeah, Florida, 33012
Eastern Research, Inc
Hialeah, Florida, 33013
Centex Studies, Inc.
Houston, Texas, 77062
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
Health Awareness, Inc.
Jupiter, Florida, 33458
Jupiter Research, Inc.
Jupiter, Florida, 33458
Grossmont Center for Clinical Research
La Mesa, California, 91942
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502
MNH Surgical Center
Maitland, Florida, 32751
Great Lakes Gastroenterology
Mentor, Ohio, 44060
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Genoma Research Group, Inc.
Miami, Florida, 33165
Columbus Clinical Services, LLC
Miami, Florida, 33174
South Medical Research Group, Inc.
Miami, Florida, 33186
Novex Clinical Research, LLC
New Bedford, Massachusetts, 02740
Women Under Study, LLC
New Orleans, Louisiana, 70115
St. Luke's Hospital
New York, New York, 10025
Central Sooner Research
Norman, Oklahoma, 73071
Southeast Medical Research
North Charleston, South Carolina, 29406
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Lynn Health Science Institute
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, LLC
Owensboro, Kentucky, 42303
Healthcare Partners Medical Group
Pasadena, California, 91105
Elite Clinical Trials, LLC
Phoenix, Arizona, 85018
North Texas Family Medicine
Plano, Texas, 75093
Urology Center of Florida
Pompano Beach, Florida, 33060
Accord Clinical Research, LLC
Port Orange, Florida, 32129
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Rockford Gastroenterology Associates
Rockford, Illinois, 61107
Prism Research
Saint Paul, Minnesota, 55114
Quality Research, Inc.
San Antonio, Texas, 78209
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
San Antonio, Texas, 78228
Medical Center for Clinical Research
San Diego, California, 92108
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Pioneer Research Solutions, Inc.
Sugar Land, Texas, 77479
Palmetto Clinical Research
Summerville, South Carolina, 29485
Meridien Research
Tampa, Florida, 33606
Center for Digestive Health
Troy, Michigan, 48098
Genova Clinical Research, Inc.
Tucson, Arizona, 85704
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Memorial Research Medical Clinic d/b/a Orange Country Research Center
Tustin, California, 92780
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Palm Beach Research Center
West Palm Beach, Florida, 33409
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
Clinical Research of Central Florida
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
Read the detailed description
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).
- Being tested
- Plecanatide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlecanatideDrug
Also called Trulance
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Plecanatide 0.3mg | Active comparator | Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks Receives: Drug: Plecanatide |
| Plecanatide 1.0mg | Active comparator | Plecanatide 1.0mg one tablet by mouth daily for 12 weeks Receives: Drug: Plecanatide |
| Plecanatide 3.0mg | Active comparator | Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks Receives: Drug: Plecanatide |
| Plecanatide 9.0mg | Active comparator | Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks Receives: Drug: Plecanatide |
| Placebo | Placebo comparator | Placebo, one tablet by mouth daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. 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.
Measured: 12 weeks Treatment Period
Secondary outcomes (3)
Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.
Measured: 12-Week Treatment Period
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
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 Scores Over 12-Week Treatment Period (mITT Population)
The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = 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 posted6 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionOct 2014
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.
- Other trials for Irritable Bowel Syndrome Characterized by 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip B Miner, MD, Principal investigator, Oklahoma Foundation for Digestive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722318
- Sponsor's protocol ID
- SP304-20212
- Acronym
- CIBS
- Status last verified
- May 2019
- First submitted
- 2 Nov 2012
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
- ClinicalTrials.gov ID
- NCT01722318
- Acronym / sponsor ID
- CIBS / SP304-20212
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Posted 17 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
Detailed description
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Plecanatide 0.3mg | Active comparator | Drug: PlecanatidePlecanatide 0.3mg, one tablet by mouth daily for 12 weeks |
| Plecanatide 1.0mg | Active comparator | Drug: PlecanatidePlecanatide 1.0mg one tablet by mouth daily for 12 weeks |
| Plecanatide 3.0mg | Active comparator | Drug: PlecanatidePlecanatide 3.0mg, one tablet by mouth daily for 12 weeks |
| Plecanatide 9.0mg | Active comparator | Drug: PlecanatidePlecanatide 9.0mg, one tablet by mouth daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, one tablet by mouth daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged 18-75, inclusive
- Body Mass Index = 18-35 kg/m2, inclusive
- Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
- Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
- Hard or lumpy stools ≥ 25 % of defecations
Key exclusion criteria (8 listed)
- Loose stool (mushy) or watery 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 period
- Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
- 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
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: Trulance | Drug | Plecanatide 0.3mg, Plecanatide 1.0mg, Plecanatide 3.0mg, Plecanatide 9.0mg |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
Time frame: 12 weeks Treatment Period
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. 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.
3 secondary outcomes
Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
Time frame: 12-Week Treatment Period
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
Time frame: 12-Week Treatment Period
Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)
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 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip B Miner, MD principal investigator
Oklahoma Foundation for Digestive Research
99 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plecanatide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Bausch Health Americas, Inc. at 99 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 9 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 99 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Sep 2018). 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?
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population) (time frame: 12 weeks Treatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.