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26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation

This study has been terminated.
(Terminated due to a distribution issue with the trial medication)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827592
First Posted: April 9, 2013
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
Results First Submitted: July 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Idiopathic Constipation
Interventions: Drug: Elobixibat 10 mg
Drug: Elobixibat 5 mg
Drug: Placebo

  Participant Flow
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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
The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomization to a 26-week Treatment Period. A total of 909 patients were screened in the trial and of these 533 patients were excluded due to screening failure.

Reporting Groups
  Description
EBX 10 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
EBX 5 Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
PLCBO Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.

Participant Flow:   Overall Study
    EBX 10   EBX 5   PLCBO
STARTED   126 [1]   126 [1]   124 [1] 
Safety Analysis Set   125 [2]   126   124 
COMPLETED   52   46   48 
NOT COMPLETED   74   80   76 
Adverse Event                11                9                2 
Physician Decision                0                2                1 
Protocol Violation                2                1                0 
Lost to Follow-up                1                2                2 
Withdrawal by Subject                12                11                11 
Patient's substantial non-compliance                1                1                6 
Trial terminated by Sponsor                47                53                51 
Others                0                1                3 
[1] Randomized patients.
[2] 1 patient withdrew consent before getting the treatment.



  Baseline Characteristics
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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.
Intention-to-treat population

Reporting Groups
  Description
EBX 10 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
EBX 5 Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
PLCBO Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Total Total of all reporting groups

Baseline Measures
   EBX 10   EBX 5   PLCBO   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   126   124   376 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   110   113   112   335 
>=65 years   16   13   12   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.0  (14.3)   45.8  (14.1)   46.1  (14.4)   46.6  (14.3) 
Gender 
[Units: Participants]
       
Female   104   107   103   314 
Male   22   19   21   62 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   26   32   28   86 
Not Hispanic or Latino   100   94   96   290 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   1   0   1   2 
Asian   2   4   7   13 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   28   23   29   80 
White   95   97   87   279 
More than one race   0   2   0   2 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Canada   6   6   5   17 
Czech Republic   2   2   2   6 
Belgium   2   2   2   6 
United States   73   78   77   228 
Poland   2   1   0   3 
United Kingdom   12   10   9   31 
South Africa   14   11   14   39 
Germany   15   16   15   46 
Weekly number of CSBM [1] 
[Units: CSBM per week]
Mean (Standard Deviation)
 0.36  (0.66)   0.44  (0.75)   0.54  (0.82)   0.45  (0.75) 
[1]

CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).

Baseline value for the number of CSBM per week was defined as the average of the numbers of CSBM per week for over the 2-week Pretreatment Period.

Weekly number of SBM [1] 
[Units: SBM per week]
Mean (Standard Deviation)
 2.20  (1.34)   2.13  (1.27)   2.31  (1.43)   2.21  (1.35) 
[1]

SBM was defined as a bowel movement that occurs in the absence of a laxative use or manual disimpaction.

Baseline value for the number of SBM was defined as the average of the numbers of SBM per week for over the 2-week Pretreatment Period.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Complete Spontaneous Bowel Movement (CSBM) Response   [ Time Frame: During the first 12 weeks ]

2.  Secondary:   Occurrence of CSBM Response   [ Time Frame: Within the first 24 hours of treatment initiation ]

3.  Secondary:   Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)   [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

4.  Secondary:   Change From Baseline in Weekly Stool Consistency of SBMs   [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

5.  Secondary:   Total Patient Assessment of Constipation – Quality of Life (PAC-QOL) Score Responder   [ Time Frame: At 12 weeks ]

6.  Secondary:   Change From Baseline in Weekly Degree of Straining of SBMs   [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

7.  Secondary:   Change From Baseline in Weekly Abdominal Bloating Score   [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

8.  Secondary:   Change From Baseline in Weekly Abdominal Discomfort Score   [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Due to the early termination of the study, outcomes were presented only for descriptive purposes.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com



Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01827592     History of Changes
Other Study ID Numbers: 000079
2012-005587-94 ( EudraCT Number )
First Submitted: April 5, 2013
First Posted: April 9, 2013
Results First Submitted: July 17, 2015
Results First Posted: October 20, 2015
Last Update Posted: October 20, 2015