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The Plecanatide Chronic Idiopathic Constipation (CIC) Study

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ClinicalTrials.gov Identifier: NCT01429987
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Idiopathic Constipation
Interventions: Drug: plecanatide
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Plecanatide 0.3 mg Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
Plecanatide 1.0 mg Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
Plecanatide 3.0 mg Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
Placebo Subjects received placebo orally for 12 consecutive weeks

Participant Flow:   Overall Study
    Plecanatide 0.3 mg   Plecanatide 1.0 mg   Plecanatide 3.0 mg   Placebo
STARTED   238   238   238   237 
COMPLETED   189   176   202   171 
NOT COMPLETED   49   62   36   66 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment. 951 patients were randomized; 3 were not treated and 2 received study drug but did not complete a post-dose assessment, yielding 946 patients in the mITT population.

Reporting Groups
  Description
Plecanatide 0.3 mg Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
Plecanatide 1.0 mg Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
Plecanatide 3.0 mg Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
Placebo Subjects received placebo orally for 12 consecutive weeks
Total Total of all reporting groups

Baseline Measures
   Plecanatide 0.3 mg   Plecanatide 1.0 mg   Plecanatide 3.0 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 237   238   237   234   946 
Age 
[Units: Years]
Mean (Full Range)
 47.8 
 (20 to 75) 
 47.1 
 (18 to 75) 
 47.1 
 (18 to 75) 
 46.3 
 (19 to 75) 
 47.1 
 (18 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      203  85.7%      202  84.9%      205  86.5%      207  88.5%      817  86.4% 
Male      34  14.3%      36  15.1%      32  13.5%      27  11.5%      129  13.6% 


  Outcome Measures

1.  Primary:   Overall Responder 9/12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Reduction in Straining and Abdominal Symptoms Such as Pain, Discomfort and Bloating.   [ Time Frame: 12 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Patrick H. Griffin
Organization: Synergy Pharmaceuticals Inc.
phone: 212-297-0020



Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01429987     History of Changes
Other Study ID Numbers: SP304-20210
SP-SP30420210
First Submitted: September 6, 2011
First Posted: September 7, 2011
Results First Submitted: October 25, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017