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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)

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.
 
ClinicalTrials.gov Identifier: NCT02299570
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : July 27, 2018
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Enterocolitis Clostridium Difficile Recurrent
Interventions Biological: RBX2660 (microbiota suspension)
Other: Placebo
Enrollment 150
Recruitment Details Recruitment was from 12/10/14 to 11/13/15 at 21 medical clinics in the United States and Canada. Recruiment was performed by trained investigators and study coordinators.
Pre-assignment Details Seventeen enrolled subjects did not proceed to randomization and were exited from the study. Of the 133 randomized subjects remaining, five subjects chose to withdraw prior to treatment and in one subject the first blinded enema was not able to be initiated due to anxiety and the subject subsequently chose to withdraw.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Period Title: Overall Study
Started 45 44 44
Completed 31 35 25
Not Completed 14 9 19
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Total of all reporting groups
Overall Number of Baseline Participants 45 44 44 133
Hide Baseline Analysis Population Description
This analysis population corresponds to the Intent to Treat Analysis Population. It includes subjects that were randomized into the treatment groups, but not treated, as well as one subject who was randomized into Group C, but received treatment as if in Group A.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
<=18 years
0
   0.0%
0
   0.0%
1
   2.3%
1
   0.8%
Between 18 and 65 years
19
  42.2%
25
  56.8%
25
  56.8%
69
  51.9%
>=65 years
26
  57.8%
19
  43.2%
18
  40.9%
63
  47.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 44 participants 133 participants
63.6  (19.15) 58.8  (19.24) 61.0  (19.69) 61.1  (19.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
Female
26
  57.8%
30
  68.2%
25
  56.8%
81
  60.9%
Male
19
  42.2%
14
  31.8%
19
  43.2%
52
  39.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
Hispanic or Latino
1
   2.2%
2
   4.5%
1
   2.3%
4
   3.0%
Not Hispanic or Latino
43
  95.6%
42
  95.5%
42
  95.5%
127
  95.5%
Unknown or Not Reported
1
   2.2%
0
   0.0%
1
   2.3%
2
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.3%
2
   4.5%
3
   2.3%
White
44
  97.8%
43
  97.7%
42
  95.5%
129
  97.0%
More than one race
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.8%
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 45 participants 44 participants 44 participants 133 participants
Canada 12 8 8 28
United States 33 36 36 105
1.Primary Outcome
Title Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
Hide Description The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
Time Frame 8 weeks after last assigned study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - Subjects in the ITT that were randomized, but not treated, as well as subjects with an "indeterminate" treatment outcome, were also conservatively treated as treatment failures.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

Two enemas of RBX2660 (microbiota suspension) administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 45 44
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Success
25
  55.6%
19
  43.2%
Treatment Failure
20
  44.4%
25
  56.8%
2.Secondary Outcome
Title Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Hide Description Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group B Group C
Hide Arm/Group Description:

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 44 44
Measure Type: Count of Participants
Unit of Measure: Participants
Success
19
  43.2%
25
  56.8%
Failure
25
  56.8%
19
  43.2%
3.Secondary Outcome
Title Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Hide Description Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group A Group C
Hide Arm/Group Description:

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 45 44
Measure Type: Count of Participants
Unit of Measure: Participants
Success
25
  55.6%
25
  56.8%
Failure
20
  44.4%
19
  43.2%
4.Secondary Outcome
Title SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
Hide Description The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
Time Frame 8-week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Two enemas of RBX2660 (microbiota suspension) administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 45 44 44
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Physical Comp Baseline Number Analyzed 39 participants 44 participants 42 participants
39.4  (11.4) 39.4  (9.7) 43.4  (10.5)
Physical Comp Week 1 Number Analyzed 32 participants 30 participants 28 participants
44.3  (10.2) 45.0  (9.7) 46.4  (10.1)
Physical Comp Week 4 Number Analyzed 33 participants 31 participants 29 participants
44.9  (11.6) 45.6  (10.2) 46.1  (11.2)
Physical Comp Week 8 Number Analyzed 33 participants 31 participants 32 participants
43.9  (10.9) 45.8  (10.6) 46.5  (12.1)
Mental Comp Baseline Number Analyzed 40 participants 44 participants 42 participants
44.6  (13.5) 42.5  (11.5) 45.0  (11.9)
Mental Comp Week 1 Number Analyzed 32 participants 30 participants 28 participants
51.8  (10.5) 51.2  (10.3) 50.6  (8.2)
Mental Comp Week 4 Number Analyzed 33 participants 31 participants 29 participants
53.5  (10.7) 48.2  (12.4) 51.5  (6.4)
Mental Comp Week 8 Number Analyzed 33 participants 31 participants 32 participants
52.1  (10.8) 49.8  (11.7) 51.2  (7.6)
5.Secondary Outcome
Title Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Hide Description Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group A Group B
Hide Arm/Group Description:

Two enemas of RBX2660 (microbiota suspension) administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 45 44
Measure Type: Number
Unit of Measure: percentage of participants
% Recurrence Free by Day 0 Number Analyzed 45 participants 44 participants
91.1 100
% Recurrence Free by Day 7 Number Analyzed 35 participants 35 participants
73.3 77.3
% Recurrence Free by Day 14 Number Analyzed 30 participants 30 participants
66.7 63.6
% Recurrence Free by Day 21 Number Analyzed 27 participants 27 participants
60.0 61.4
% Recurrence Free by Day 28 Number Analyzed 27 participants 25 participants
60.0 56.8
% Recurrence Free by Day 35 Number Analyzed 27 participants 23 participants
57.8 52.3
% Recurrence Free by Day 42 Number Analyzed 26 participants 22 participants
57.8 50.0
% Recurrence Free by Day 49 Number Analyzed 24 participants 21 participants
55.5 47.6
% Recurrence Free by Day 56 Number Analyzed 23 participants 14 participants
55.5 42.2
6.Secondary Outcome
Title Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Hide Description Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group C Group B
Hide Arm/Group Description:

One enemas of RBX2660 (microbiota suspension) and one enema of Placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: percentage of participants
% Recurrence Free by 2nd Enema Number Analyzed 44 participants 44 participants
95.5 100
% Recurrence Free by Day 7 Number Analyzed 37 participants 35 participants
76.9 77.3
% Recurrence Free by Day 14 Number Analyzed 31 participants 30 participants
69.9 63.6
% Recurrence Free by Day 21 Number Analyzed 28 participants 27 participants
62.9 61.4
% Recurrence Free by Day 28 Number Analyzed 27 participants 25 participants
62.9 56.8
% Recurrence Free by Day 35 Number Analyzed 26 participants 23 participants
60.6 52.3
% Recurrence Free by Day 42 Number Analyzed 25 participants 22 participants
55.9 50.0
% Recurrence Free by Day 49 Number Analyzed 23 participants 21 participants
55.9 47.6
% Recurrence Free by Day 56 Number Analyzed 20 participants 14 participants
55.9 42.2
7.Secondary Outcome
Title Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Hide Description Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group A Group C
Hide Arm/Group Description:

Two enemas of RBX2660 (microbiota suspension) administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

One enema of RBX2660 (microbiota suspension) and one enema of Placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 45 44
Measure Type: Number
Unit of Measure: percentage of participants
% Recurrence Free by 2nd Enema Number Analyzed 45 participants 44 participants
91.1 95.5
% Recurrence Free by Day 7 Number Analyzed 35 participants 37 participants
73.3 76.9
% Recurrence Free by Day 14 Number Analyzed 30 participants 31 participants
66.7 69.9
% Recurrence Free by Day 21 Number Analyzed 27 participants 28 participants
60.0 62.9
% Recurrence Free by Day 28 Number Analyzed 27 participants 27 participants
60.0 62.9
% Recurrence Free by Day 35 Number Analyzed 27 participants 26 participants
57.8 60.6
% Recurrence Free by Day 42 Number Analyzed 26 participants 25 participants
57.8 55.9
% Recurrence Free by Day 49 Number Analyzed 24 participants 23 participants
55.5 55.9
% Recurrence Free by Day 56 Number Analyzed 23 participants 20 participants
55.5 55.9
Time Frame 24 months
Adverse Event Reporting Description Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/42 (16.67%)      2/44 (4.55%)      6/42 (14.29%)    
Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/42 (42.86%)      8/44 (18.18%)      12/42 (28.57%)    
Blood and lymphatic system disorders       
Anaemia  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Leukocytosis  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Cardiac disorders       
Cardiac failure congestive  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  3
Angina pectoris  1  2/42 (4.76%)  2 0/44 (0.00%)  0 1/42 (2.38%)  1
Acute myocardial infarction  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Myocardial infarction  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Congenital, familial and genetic disorders       
Arnold-Chiari malformation  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain  1  1/42 (2.38%)  1 1/44 (2.27%)  1 0/42 (0.00%)  0
Constipation  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Diarrhoea  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Gastrointestinal haemorrhage  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Intestinal obstruction  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Abdominal discomfort  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Abdominal distension  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Abdominal Pain Upper  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Intestinal ischaemia  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Intestinal mass  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Malocclusion  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Small intestinal obstruction  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
General disorders       
Fatigue  1  0/42 (0.00%)  0 1/44 (2.27%)  1 1/42 (2.38%)  1
General physical health deterioration  1  0/42 (0.00%)  0 0/44 (0.00%)  0 2/42 (4.76%)  2
Pyrexia  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations       
Osteomyelitis chronic  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Pneumonia  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Sepsis  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Urinary Tract Infection  1  2/42 (4.76%)  2 0/44 (0.00%)  0 1/42 (2.38%)  1
Influenza  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Clostridium difficile infection  1  1/42 (2.38%)  1 1/44 (2.27%)  3 0/42 (0.00%)  0
Appendicitis perforated  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Bronchitis viral  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Cellulitis  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Ear Infection  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Sinusitis  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Urinary Tract Infection Bacterial  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Injury, poisoning and procedural complications       
Concussion  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Extradural haematoma  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Wound  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/42 (0.00%)  0 2/44 (4.55%)  2 0/42 (0.00%)  0
Hyponatraemia  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Failure to thrive  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Bunion  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcimoa  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Small cell carcinoma  1  0/42 (0.00%)  0 1/44 (2.27%)  2 0/42 (0.00%)  0
Brain neoplasm  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Metastases to meninges  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Thymoma  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Nervous system disorders       
Parkinsonism  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Cerebrovascular accident  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Diabetic neuropathy  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Embolic stroke  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Nerve compression  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Neuropathy peripheral  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Paraplegia  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Serotonin syndrome  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Transient ischaemic attack  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Psychiatric disorders       
Mental status changes  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Bipolar disorder  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  1/42 (2.38%)  1 1/44 (2.27%)  1 0/42 (0.00%)  0
Renal failure acute  1  0/42 (0.00%)  0 1/44 (2.27%)  1 1/42 (2.38%)  1
Calculus ureteric  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Renal colic  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Renal impairment  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Ureteric stenosis  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  2
Respiratory failure  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  2
Acute Respiratory Failure  1  1/42 (2.38%)  2 0/44 (0.00%)  0 1/42 (2.38%)  1
Dyspnoea  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Mediastinal mass  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin ulcer  1  0/42 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1
Skin lesion  1  1/42 (2.38%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0
Vascular disorders       
Arterial thrombosis  1  0/42 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/42 (57.14%)      19/44 (43.18%)      20/42 (47.62%)    
Blood and lymphatic system disorders       
Anaemia  1  3/42 (7.14%)  3 0/44 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders       
Abdominal distension  1  3/42 (7.14%)  4 3/44 (6.82%)  3 2/42 (4.76%)  2
Abdominal Pain  1  10/42 (23.81%)  13 8/44 (18.18%)  10 8/42 (19.05%)  9
Anorectal discomfort  1  3/42 (7.14%)  4 3/44 (6.82%)  4 2/42 (4.76%)  2
Diarrhoea  1  17/42 (40.48%)  27 7/44 (15.91%)  10 5/42 (11.90%)  7
Nausea  1  4/42 (9.52%)  8 1/44 (2.27%)  1 4/42 (9.52%)  4
Constipation  1  6/42 (14.29%)  9 2/44 (4.55%)  2 3/42 (7.14%)  3
Flatulence  1  4/42 (9.52%)  4 2/44 (4.55%)  2 4/42 (9.52%)  4
Haematochezia  1  1/42 (2.38%)  1 0/44 (0.00%)  0 3/42 (7.14%)  3
Proctalgia  1  0/42 (0.00%)  0 3/44 (6.82%)  3 1/42 (2.38%)  1
General disorders       
Pyrexia  1  1/42 (2.38%)  1 3/44 (6.82%)  3 6/42 (14.29%)  7
Chills  1  2/42 (4.76%)  5 4/44 (9.09%)  5 1/42 (2.38%)  1
Fatigue  1  3/42 (7.14%)  3 1/44 (2.27%)  1 1/42 (2.38%)  1
Infections and infestations       
Urinary Tract Infection  1  5/42 (11.90%)  11 2/44 (4.55%)  2 0/42 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  1/42 (2.38%)  1 1/44 (2.27%)  1 3/42 (7.14%)  5
Contusion  1  0/42 (0.00%)  0 3/44 (6.82%)  3 1/42 (2.38%)  1
Metabolism and nutrition disorders       
Dehydration  1  3/42 (7.14%)  3 1/44 (2.27%)  1 1/42 (2.38%)  1
Nervous system disorders       
Headache  1  3/42 (7.14%)  4 2/44 (4.55%)  2 1/42 (2.38%)  1
Vascular disorders       
Orthostatic hypotension  1  3/42 (7.14%)  3 0/44 (0.00%)  0 0/42 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Assoc. Director of Clinical Research
Organization: Rebiotix
Phone: 651-705-8778
EMail: Sarah.Mische@Ferring.com
Layout table for additonal information
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT02299570    
Other Study ID Numbers: 2014-01
First Submitted: November 19, 2014
First Posted: November 24, 2014
Results First Submitted: July 2, 2018
Results First Posted: July 27, 2018
Last Update Posted: January 15, 2021