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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
Enrollment 314
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
Hide Arm/Group Description 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). 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). 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). 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). 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).
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title EBX 10 EBX 5 PLCBO Total
Hide Arm/Group Description Elobixibat 10 mg/day was administered orally in a tablet form. Elobixibat 5 mg/day was administered orally in a tablet form. Placebo was administered orally in a tablet form. Total of all reporting groups
Overall Number of Baseline Participants 103 100 111 314
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 100 participants 111 participants 314 participants
49.6  (14.3) 49.5  (13.5) 48.0  (16.1) 49.0  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 111 participants 314 participants
Female
84
  81.6%
85
  85.0%
97
  87.4%
266
  84.7%
Male
19
  18.4%
15
  15.0%
14
  12.6%
48
  15.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 111 participants 314 participants
Hispanic or Latino
9
   8.7%
9
   9.0%
11
   9.9%
29
   9.2%
Not Hispanic or Latino
94
  91.3%
91
  91.0%
100
  90.1%
285
  90.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 111 participants 314 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.9%
1
   1.0%
2
   1.8%
5
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  15.5%
13
  13.0%
16
  14.4%
45
  14.3%
White
85
  82.5%
86
  86.0%
93
  83.8%
264
  84.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 111 participants 314 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] 
Mean (Standard Deviation)
Unit of measure:  CSBM per week
Number Analyzed 103 participants 100 participants 111 participants 314 participants
0.33  (0.62) 0.32  (0.62) 0.43  (0.68) 0.36  (0.64)
[1]
Measure Description:

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] 
Mean (Standard Deviation)
Unit of measure:  SBM per week
Number Analyzed 103 participants 100 participants 111 participants 314 participants
2.31  (1.27) 2.19  (1.13) 2.45  (1.35) 2.32  (1.26)
[1]
Measure Description:

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.

1.Primary Outcome
Title Overall Complete Spontaneous Bowel Movement (CSBM) Response
Hide Description This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.
Time Frame During the first 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Measure Type: Number
Unit of Measure: Percentage of patients
12.6 15.0 8.1
2.Secondary Outcome
Title Occurrence of CSBM Response
Hide Description This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A 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’).
Time Frame Within first 24 hours of treatment initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Measure Type: Number
Unit of Measure: Percentage of patients
21.4 13.0 13.5
3.Secondary Outcome
Title Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)
Hide Description The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.
Time Frame From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Least Squares Mean (95% Confidence Interval)
Unit of Measure: SBM per week
2.25
(1.78 to 2.71)
2.40
(1.92 to 2.88)
1.20
(0.74 to 1.66)
4.Secondary Outcome
Title Change From Baseline in Weekly Stool Consistency of SBMs
Hide Description

The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.

Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .

For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Time Frame From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on BSFS
1.56
(1.35 to 1.77)
1.45
(1.24 to 1.66)
0.80
(0.60 to 1.00)
5.Secondary Outcome
Title Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder
Hide Description

This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.

PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.

Total PAC-QOL score was averaged from the individual item score.

Time Frame At Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Measure Type: Number
Unit of Measure: Percentage of patients
33.0 31.0 18.9
6.Secondary Outcome
Title Change From Baseline in Weekly Degree of Straining of SBMs
Hide Description

The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).

For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Time Frame From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.90
(-1.03 to -0.77)
-0.84
(-0.97 to -0.71)
-0.63
(-0.76 to -0.50)
7.Secondary Outcome
Title Change From Baseline in Weekly Abdominal Bloating Score
Hide Description

The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Time Frame From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.46
(-0.56 to -0.36)
-0.35
(-0.46 to -0.25)
-0.30
(-0.40 to -0.20)
8.Secondary Outcome
Title Change From Baseline in Weekly Abdominal Discomfort Score
Hide Description

The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Time Frame From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisting of all randomized (as planned) patients.
Arm/Group Title EBX 10 EBX 5 PLCBO
Hide Arm/Group Description:
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
Overall Number of Participants Analyzed 103 100 111
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.37
(-0.48 to -0.27)
-0.32
(-0.43 to -0.22)
-0.25
(-0.36 to -0.15)
Time Frame 6 months
Adverse Event Reporting Description The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
 
Arm/Group Title EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
Hide Arm/Group Description Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period. Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period. Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period. Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period. Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
All-Cause Mortality
EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/53 (0.00%)      0/35 (0.00%)      1/50 (2.00%)      3/110 (2.73%)    
Infections and infestations           
Tonsillitis  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 0/50 (0.00%)  0 1/110 (0.91%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine leiomyoma  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 0/50 (0.00%)  0 1/110 (0.91%)  1
Basal cell carcinoma  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 1/50 (2.00%)  1 0/110 (0.00%)  0
Reproductive system and breast disorders           
Metrorrhagia  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 0/50 (0.00%)  0 1/110 (0.91%)  1
Surgical and medical procedures           
Hysterectomy  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 0/50 (0.00%)  0 1/110 (0.91%)  1
Vascular disorders           
Hypertension  1  0/65 (0.00%)  0 0/53 (0.00%)  0 0/35 (0.00%)  0 0/50 (0.00%)  0 1/110 (0.91%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/65 (38.46%)      11/53 (20.75%)      13/35 (37.14%)      20/50 (40.00%)      24/110 (21.82%)    
Gastrointestinal disorders           
Diarrhoea  1  13/65 (20.00%)  17 2/53 (3.77%)  12 1/35 (2.86%)  2 5/50 (10.00%)  7 4/110 (3.64%)  5
Abdominal pain  1  9/65 (13.85%)  11 3/53 (5.66%)  3 2/35 (5.71%)  2 1/50 (2.00%)  1 6/110 (5.45%)  9
Nausea  1  6/65 (9.23%)  6 0/53 (0.00%)  0 1/35 (2.86%)  1 0/50 (0.00%)  0 2/110 (1.82%)  2
Abdominal pain upper  1  3/65 (4.62%)  3 1/53 (1.89%)  1 0/35 (0.00%)  0 3/50 (6.00%)  3 1/110 (0.91%)  1
Abdominal pain lower  1  2/65 (3.08%)  2 0/53 (0.00%)  0 2/35 (5.71%)  3 0/50 (0.00%)  0 2/110 (1.82%)  2
General disorders           
Pain  1  0/65 (0.00%)  0 0/53 (0.00%)  0 2/35 (5.71%)  2 0/50 (0.00%)  0 0/110 (0.00%)  0
Infections and infestations           
Urinary tract infection  1  2/65 (3.08%)  2 2/53 (3.77%)  2 1/35 (2.86%)  1 4/50 (8.00%)  4 5/110 (4.55%)  5
Sinusitis  1  3/65 (4.62%)  3 3/53 (5.66%)  3 0/35 (0.00%)  0 3/50 (6.00%)  3 1/110 (0.91%)  1
Upper respiratory tract infection  1  1/65 (1.54%)  1 1/53 (1.89%)  1 2/35 (5.71%)  2 3/50 (6.00%)  3 3/110 (2.73%)  3
Nasopharyngitis  1  0/65 (0.00%)  0 1/53 (1.89%)  1 1/35 (2.86%)  1 4/50 (8.00%)  5 3/110 (2.73%)  3
Nervous system disorders           
Headache  1  3/65 (4.62%)  3 0/53 (0.00%)  0 2/35 (5.71%)  5 0/50 (0.00%)  0 2/110 (1.82%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Due to the early termination of the study, outcomes were presented only for descriptive purposes.
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 only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
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