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

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ClinicalTrials.gov Identifier: NCT01982240
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : March 21, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Plecanatide Drug: Placebo Drug: Bisacodyl Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Plecanatide 3.0 mg
Plecanatide tablets 3.0 mg QD for 12 weeks
Drug: Plecanatide
Plecanatide tablets QD for 12 weeks
Other Name: Trulance

Active Comparator: Plecanatide 6.0 mg
Plecanatide tablets 6.0 mg QD for 12 weeks
Drug: Plecanatide
Plecanatide tablets QD for 12 weeks
Other Name: Trulance

Placebo Comparator: Placebo
Matching placebo tablets QD for 12 weeks
Drug: Placebo
Matching placebo tablets QD for 12 weeks
Other Name: Trulance placebo

Bisacodyl
Rescue medication
Drug: Bisacodyl
Rescue medication
Other Name: Dulcolax




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach [ Time Frame: 12-Week Treatment Period ]
    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.

  2. Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach [ Time Frame: 12-Week Treatment Period ]
    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.

  3. Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach [ Time Frame: 12-Week 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)

  4. Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach [ Time Frame: 12-Week Treatment Period ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982240


Locations
Show Show 189 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Mary Beth Layton Synergy Pharmaceuticals Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01982240    
Other Study ID Numbers: SP304203-00
First Posted: November 13, 2013    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: December 26, 2019
Last Verified: December 2019
Keywords provided by Bausch Health Americas, Inc.:
CIC
Constipation
Chronic Constipation
Synergy
Plecanatide
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Bisacodyl
Plecanatide
Cathartics
Gastrointestinal Agents
Laxatives
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action