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Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT01833065
Recruitment Status : Terminated (Terminated due to a distribution issue with the trial medication)
First Posted : April 16, 2013
Results First Posted : October 20, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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/day
Drug: Elobixibat 5 mg/day
Drug: 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
Trial included 4-week Screening and 2-week Pretreatment Period before patient randomization to treatment sequences i.e. EBX 10/EBX 10, EBX 10/PLCBO, EBX 5/EBX 5, EBX 5/PLCBO and PLCBO/EBX 10. The total study duration was of 16 weeks: the efficacy assessments focused on the first 12 weeks, while safety assessments focused on whole 16 weeks

Reporting Groups
  Description
EBX 10/EBX 10 Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
EBX 10/PLCBO Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
EBX 5/EBX 5 Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
EBX 5/PLCBO Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
PLCBO/EBX 10 Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).

Participant Flow:   Overall Study
    EBX 10/EBX 10   EBX 10/PLCBO   EBX 5/EBX 5   EBX 5/PLCBO   PLCBO/EBX 10
STARTED   65 [1]   53 [1]   35 [1]   50 [1]   110 [1] 
Intention-to-treat Analysis Set   50 [2]   53 [2]   50 [2]   50 [2]   111 [2] 
COMPLETED   41   40   23   41   74 
NOT COMPLETED   24   13   12   9   36 
Adverse Event                6                1                0                2                3 
Protocol Violation                1                0                0                0                2 
Lost to Follow-up                1                0                0                0                3 
Withdrawal by Subject                6                2                4                3                11 
Subject's substantial non-compliance                0                1                0                0                0 
Trial terminated by sponsor                8                8                7                3                13 
Others                2                1                1                1                4 
[1] Randomized patients - As treated
[2] Randomized patients



  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.
Intention-to-treat (ITT) analysis set.

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

Baseline Measures
   EBX 10   EBX 5   PLCBO   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   100   111   314 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (14.3)   49.5  (13.5)   48.0  (16.1)   49.0  (14.7) 
Gender 
[Units: Participants]
       
Female   84   85   97   266 
Male   19   15   14   48 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   9   9   11   29 
Not Hispanic or Latino   94   91   100   285 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   2   1   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   16   13   16   45 
White   85   86   93   264 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Canada   1   2   1   4 
Czech Republic   2   2   0   4 
Sweden   1   2   3   6 
Hungary   15   13   14   42 
United States   49   54   55   158 
Poland   3   4   3   10 
South Africa   12   7   13   32 
United Kingdom   11   9   12   32 
Slovakia   5   3   5   13 
Germany   4   4   5   13 
Weekly number of CSBM [1] 
[Units: CSBM per week]
Mean (Standard Deviation)
 0.33  (0.62)   0.32  (0.62)   0.43  (0.68)   0.36  (0.64) 
[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)
 2.31  (1.27)   2.19  (1.13)   2.45  (1.35)   2.32  (1.26) 
[1]

SBM was defined as a bowel movement that occurred 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

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 first 24 hours of treatment initiation ]

3.  Secondary:   Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (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 Week 12 ]

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

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

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: NCT01833065     History of Changes
Other Study ID Numbers: 000080
2012-005588-28 ( EudraCT Number )
First Submitted: April 12, 2013
First Posted: April 16, 2013
Results First Submitted: July 17, 2015
Results First Posted: October 20, 2015
Last Update Posted: October 20, 2015