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Search Results within category "Digestive Systems & Liver Disease"

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Suggestions within category "Digestive Systems & Liver Disease"


5 Study Matches

;Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

This study is for patients who have been diagnosed with moderate to severe Crohn's disease (CD) or have signs and symptoms of moderate to severe Crohn's disease. This is a drug study that will examine if Ozanomid is safe and effective in treating patients with CD.
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Symptoms consistent with Crohn's disease for at least 3 months
Inadequate response or loss of response to Crohn's treatment
At high risk for cancer of the colon
Exclusion Criteria:
Has other diagnosis of colon disease(s)
Have an ostomy
History of extensive small bowel resection
Suspected infection of abdomen that has not been treated
Significant cardiovascular disease
Digestive Systems & Liver Disease
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State College, PA

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Crohn's Disease

This study is for patients with moderate to severely active Crohn's disease to measure how effective and safe an experimental medication is in treating this condition.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03599622
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Inclusion Criteria:
moderate to severe crohn's disease, 3 months
failed prior treatment
Exclusion Criteria:
severe or fulminant colitis requiring surgery
presence of stoma, gastric pouch
prior bowel resection, 6 months
bleeding disorders
cancer < 5 years
Digestive Systems & Liver Disease
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Hershey, PA

INDUCTION STUDY #1 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

This study is for patients who have been diagnosed with or have signs and symptoms of moderately to severely active Crohn's disease (CD) which is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhea, abdominal pain, rectal bleeding, weight loss, and fever. This study is being done to see whether an experimental medication that is not approved by the Food and Drug Administration, is safe and effective for the possible treatment of CD. To do this, a comparison will be made between people who receive active drug and people who receive placebo (a ‘dummy treatment’ that looks like the active drug but contains no active ingredient). The purpose of this study is to confirm preliminary results from a phase II study that suggests that the active drug may be safe and effective in treating patients with CD.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Ages 18-75, inclusive
Diagnosis of Crohn's Disease for at least 3 months
Failed prior treatment
Exclusion Criteria:
Will need surgery in 3 months
Stricture or obstruction symptoms
Prior cancers
Drug or alcohol abuse within 1 year
Diagnosis of colitis
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306)

This study is for patients with moderate to severe Crohn's disease. This research is being done to determine whether an investigational drug is safe and effective when compared to placebo (a treatment that does not contain active drug) in the treatment of patients with moderate to severe Crohn's disease.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03566823
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Inclusion Criteria:
Diagnosis of Crohn's disease for 3 months
Ages 18-80
Exclusion Criteria:
History of other forms of colitis
History of colon polyps (if removed may be eligible) or cancer
Past medical history of toxic megacolon
Current symptomatic diverticulitis or diverticulosis
Past medical history of multiple small bowel resections
Digestive Systems & Liver Disease
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State College, PA

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.

This study is for patients with Crohn's disease which involves an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). The purpose of this study is to find out: 1) How well the study drug works at a single dose compared to a placebo; 2) how safe and tolerable the study drug is in patients with fistulizing CD.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03279081
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Inclusion Criteria:
Diagnosis of Crohn's Disease for at least 6 months
Presence of complex perianal fistulas
Clinically controlled, non active or mildly active CD during the last 6 months
Patients whose perianal fistulas were previously treated and have shown an inadequate response
Exclusion Criteria:
Any major surgery of the GI tract within past 6 months
Patients without prior specific treatment for perianal complex fistulas
Patients with diverting stomas
Patients with active, uncontrolled infection requiring IV antibiotics
Patients with allergies or hypersensitivity to penicillin or aminoglycosides, local anesthetics or MRI contrast
Infectious Diseases & Immune System, Digestive Systems & Liver Disease
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Study Locations

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Location
Hershey, PA