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Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01434693
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Biological: Trichuris suis ova
Other: Placebo
Enrollment 36
Recruitment Details A total of 8 clinical sites were initiated, all in the United States, with 6 of these sites enrolling at least one patient. Patients were enrolled from Nov, 2011 to Jan 30, 2012.
Pre-assignment Details All patients were immediately assigned to a treatment group upon enrollment.
Arm/Group Title Placebo TSO 500 TSO 2500 TSO 7500
Hide Arm/Group Description Placebo: single dose Trichuris suis ova : single dose Trichuris suis ova : single dose Trichuris suis ova : single dose
Period Title: Overall Study
Started 9 9 9 9
Completed 6 9 8 8
Not Completed 3 0 1 1
Reason Not Completed
Adverse Event             1             0             0             0
Withdrawal by Subject             1             0             1             1
Lost to Follow-up             1             0             0             0
Arm/Group Title Placebo TSO 500 TSO 2500 TSO 7500 Total
Hide Arm/Group Description Placebo: single dose Trichuris suis ova : single dose Trichuris suis ova : single dose Trichuris suis ova : single dose Total of all reporting groups
Overall Number of Baseline Participants 9 9 9 9 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
9
 100.0%
9
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
43.0  (3.11) 30.8  (3.19) 31.1  (3.36) 36.9  (3.27) 32.9  (1.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Female
4
  44.4%
6
  66.7%
3
  33.3%
5
  55.6%
18
  50.0%
Male
5
  55.6%
3
  33.3%
6
  66.7%
4
  44.4%
18
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
9 9 9 9 36
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms
Time Frame 6 mo
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.
Arm/Group Title Placebo TSO 500 TSO 2500 TSO 7500
Hide Arm/Group Description:
Placebo: single dose
Trichuris suis ova : single dose
Trichuris suis ova : single dose
Trichuris suis ova : single dose
Overall Number of Participants Analyzed 9 9 9 9
Measure Type: Number
Unit of Measure: events
7 4 1 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo TSO 500 TSO 2500 TSO 7500
Hide Arm/Group Description Placebo: single dose Trichuris suis ova : single dose Trichuris suis ova : single dose Trichuris suis ova : single dose
All-Cause Mortality
Placebo TSO 500 TSO 2500 TSO 7500
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo TSO 500 TSO 2500 TSO 7500
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/9 (22.22%)   0/9 (0.00%)   0/9 (0.00%)   1/9 (11.11%) 
Gastrointestinal disorders         
ABDOMINAL PAIN  1 [1]  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Crohn's disease flare  1 [2]  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
ANOVULVAR FISTULA  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Infections and infestations         
CLOSTRIDIAL INFECTION  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Surgical and medical procedures         
small intestinal resection  1 [3]  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Patient 10-2004 (Placebo) experienced abdominal pain with questionable underlying etiology on Day 48.
[2]
Patient 09-3011 (TSO 7500) experienced three SAEs: Crohn's disease flare on Day 85 Anovaginal fistula on Day 86 Clostridium difficile infection on Day 86
[3]
Patient 01-1011 (Placebo) experienced a small intestinal resection on Day 42 following dosing. This patient discontinued from the study on Day 84 due to symptoms associated with this event.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo TSO 500 TSO 2500 TSO 7500
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   4/9 (44.44%)   1/9 (11.11%)   6/9 (66.67%) 
Gastrointestinal disorders         
Diarrhea  1  0/9 (0.00%)  3/9 (33.33%)  0/9 (0.00%)  0/9 (0.00%) 
Vomitting  1  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/9 (11.11%) 
Rectal haemorrhage  1  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/9 (11.11%) 
Nausea  1  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  1/9 (11.11%) 
Abdominal pain  1  0/9 (0.00%)  2/9 (22.22%)  0/9 (0.00%)  0/9 (0.00%) 
Mucous stools  1  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%) 
Flatulence  1  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%) 
Crohn's disease  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Aphthous stomatitis  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Gastrointestinal reflux disease  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Infections and infestations         
Sinusitis  1  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications         
Road traffic accident  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders         
Joint swelling  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Syncope  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Dysgeusia  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Headache  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Psychiatric disorders         
Insomnia  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Reproductive system and breast disorders         
Ovarian cyst  1  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Sinus congestion  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Oropharyngeal pain  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Laryngeal oedema  1  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema nodosum  1  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Layout table for Results Point of Contact information
Name/Title: Vice President Clinical Operations
Organization: Coronado Biosciences
Phone: 781.652.4516
EMail: nsilver@coronadobio.com
Layout table for additonal information
Responsible Party: Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01434693    
Other Study ID Numbers: CNDO 201-002
First Submitted: September 13, 2011
First Posted: September 15, 2011
Results First Submitted: February 26, 2013
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013