Clinical Trial

Contents
1What is a Clinical Trial? 1.1Phase 1 1.2Phase 2 1.3Phase 3 1.4Phase 4 2Clinical Trials for Adults 2.1Alternative / Complementary Therapy 2.2Drug / Medication Treatments 2.3Stem Cell Transplant 2.4Testing / Diagnosis 2.5Treatment Trends - Observational 3Clinical Trials for Pediatric Patients / Children / Kids 4References

What is a Clinical Trial?

Clinical Trial Studies are scheduled in Phases according to what question is being answered regarding a drug, test or treatment.

Phase 1

In Phase 1 (Phase I) Clinical Trials, a new drug is tested to evaluate its Safety for the first time.
- Few Patients (20 - 80)
- Find Safe Dosage of Drug
- Identify Side Effects
- Safe?

Phase 2

Phase 2 (Phase II) Clinical Trials study whether a drug is Safe and Effective
- Larger Number of Patients (100 - 300)
- Identify Short Term Side Effects
- Safe?
- Effective?

Phase 3

Phase 3 (Phase III) Clinical Trials further evaluate whether a drug is Safe and Effective and Compare it to Traditional Treatments currently on the market.
- Larger Groups of Patients (1,000 - 3,000)
- Compare to Other Threapies
- Identify / Monitor Side Effects
- Safe?
- Effective?

Phase 4

Phase 4 (Phase IV) Clinical Trials study Post-Marketing Information about the Drug / Therapy.
- Compare to Other Threapies
- Identify / Monitor Side Effects
- Further Evaluate Safety
- Further Evaluate Efficacy
- Risks?
- Benefits?
- Optimal Use of the Drug / Therapy

Clinical Trials for Adults

Alternative / Complementary Therapy

- Evaluate whether Diet and/or a Dietary Supplement, FructoOligoSaccharide (FOS), has Anti Oxidant or Prebiotic Properties to Treat Crohn's Disease (CD) - Phase 1 / Phase 2
Dietary Treatment of Crohn's Disease

- L-carnitine to Treat Fatigue Associated With Crohn's Disease
L-Carnitine Clinical Trial

Drug / Medication Treatments

- Chondroitin Sulfate for Crohn's Disease - Phase 1 / Phase 2
Chondroitin Sulfate Clinical Trial

- Colesevelam (Welchol) for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease (COBAM) - Phase 4
Colesevelam (Welchol) Clinical Trial

- Evaluation if Drug GSK1605786A (GlaxoSmithKline) can Induce Clinical Response and/or Remission in Crohn's Disease (SHIELD-4) - Phase 3
GSK1605786A (GlaxoSmithKline) Clinical Trial

- PF-04236921 (Pfizer) In Crohn's Disease Patients Who Failed Anti-TNF Therapy - Phase 2
PF-04236921 Clinical Trial

- Rifaximin / Xifaxan Antibiotic in Crohn's Disease (CD) Patients - Phase 2
Rifaximin (Xifaxan) Antibiotic Clinical Trial

- TRK-170 (Toray Industries) for the Treatment of Crohn's Disease - Phase 2
TRK-170 Clinical Trial

- Ustekinumab (Stelara) Maintenance Therapy in Crohn's Disease for Patients - Phase 3 (Invitation Only)
Stelara Invitation Only Clinical Trial

Stem Cell Transplant

Treatment of Fistulizing Crohn's Disease (CD) by Patient's Own Stem Cells derived from Fat.
Stem Cell Transplant Clinical Trial

Third Party - Mesenchymal Stromal Cells for Crohn's Disease (CD) - Phase 2
Mesenchymal Stromal Cells for Crohn's Disease

Testing / Diagnosis

- Evaluation of Crohn's Disease Endoscopic Index of Severity (CDEIS) to Capsule Endoscopy Data in Crohn Disease (CAPSCOL) - Phase 4
Capsule Endoscopy Clinical Trial

- Effectiveness of PillCam Platform in Patients with Crohn's disease (CD) - Phase 1 / Phase 2
PillCam Capsule Endoscopy Clinical Trial

- Clinical Trial to determine if Ultrasound Scan (SonoVue) can be used in Crohn's Disease (CD) Diagnosis. Comparison made with dynamic Magnetic Resonance Imaging (MRI) Testing of the Small Bowel.
Ultrasound Testing in Crohn's Disease

- Endoscopic Detection of Dysplasia in Crohn 's Disease Patients (DYDJI) at High Risk for Dysplasia or Cancer - Phase 4
Endoscopy for Dysplasia Testing in Crohn's Disease

- Immune Regulation in Ulcerative Colitis or Crohn's Disease. (This study does not involve any experimental treatments).
Immune Regulation in IBD