13 completed, 1 unknown. 6 Phase 2, 4 Phase 3, 1 Early Phase 1, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 4 | Completed 4 |
| Early Phase 1 | 1 | Unknown 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors CB-03-10 - Advanced Refractory Solid Tumors, Subjects Considered Likely to Respond to CB-03-10 | Early Phase 1 | Unknown | Cosmo Technologies Ltd | 90 | 2022-06-14 | 2024-02-07 |
| Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D Rifamycin SV 600mg t.i.d., Rifamycin SV b.i.d. + Placebo, Placebo t.i.d. - Diarrhea-predominant Irritable Bowel Syndrome | Phase 2 | Completed | Cosmo Technologies Ltd | 279 | 2017-12-18 | 2021-01-08 |
| Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) - Adenomas | Not applicable | Completed | Cosmo Technologies Ltd | 226 | 2016-02-01 | 2017-09-05 |
| Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers Rifamycin SV-MMX® 600 - Healthy | Phase 1 | Completed | Cosmo Technologies Ltd | 18 | 2015-07-01 | 2018-01-26 |
| The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy Methylene Blue MMX®, Placebo - Colorectal Cancer | Phase 3 | Completed | Cosmo Technologies Ltd | 1249 | 2013-09-01 | 2017-11-06 |
| Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA standard white light colonoscopy-equivalent to placebo, Methylene Blue MMX tablets - Colorectal Cancer | Phase 2 | Completed | Cosmo Technologies Ltd | 10 | 2013-02-01 | 2018-11-05 |
| Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy oral delivery mucosal stain - Ulcerative Colitis | Phase 2 | Completed | Cosmo Technologies Ltd | 53 | 2012-01-01 | 2019-02-08 |
| Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy oral tablet dye for detection of polyps during colonoscopy - Polyp and Adenoma Detection During Colonoscopy | Completed | Cosmo Technologies Ltd | 170 | 2012-01-01 | 2014-02-11 | |
| Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX Methylene Blue MMX 25 mg modified release tablets - Colon Staining in Preparation for Colonoscopy | Phase 2 | Completed | Cosmo Technologies Ltd | 114 | 2011-05-02 | 2021-01-28 |
| Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD) Placebo, Rifamycin SV MMX - Traveler's Diarrhea | Phase 3 | Completed | Cosmo Technologies Ltd | 264 | 2010-05-27 | 2018-06-08 |
| (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets Budesonide - Colitis, Ulcerative | Phase 3 | Completed | Bausch Health Americas, Inc. | 61 | 2010-02-01 | 2019-11-29 |
| (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis Blood sampling, endoscopy, Budesonide MMX® 6 mg, Budesonide MMX® 9 mg - Ulcerative Colitis | Phase 3 | Completed | Bausch Health Americas, Inc. | 514 | 2008-06-01 | 2019-12-10 |
| Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage - Infectious Diarrhoea | Phase 2 | Completed | Cosmo Technologies Ltd | 40 | 2008-02-01 | 2020-02-18 |
| Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy Sigmoidoscopy - Ulcerative Colitis | Phase 2 | Completed | Cosmo Technologies Ltd | 133 | 2007-01-01 | 2009-03-25 |
Colitis, Ulcerative (4) · Colorectal Neoplasms (2) · Polyps (2) · Adenoma (1) · Diarrhea (1) · Dysentery (1)
Budesonide (2) · Blood Specimen Collection (1) · Endoscopy (1) · Sigmoidoscopy (1) · rifamycin SV (1)
Italy (6) · Belgium (3) · United Kingdom (3) · United States (3) · Germany (2) · Lithuania (2) · Australia (1) · Canada (1) · Estonia (1) · France (1) · Guatemala (1) · India (1) · Israel (1) · Latvia (1) · Mexico (1)
Alessandro Repici, MD (2) · Antonio Gasbarrini, Prof (1) · Dr Douglas Rex (1) · Herbert DuPont, MD (1) · Manuel Mancera Reyes (1) · Michael Wallace, MD (1) · Silvio Danese, MD (1) · Simon Travis (1)
PMID 12538758, PMID 14996737, PMID 21563193, PMID 21868756, PMID 21969517, PMID 22223138, PMID 23341367, PMID 23436336, PMID 24131140, PMID 24315100, PMID 24615402, PMID 25535299, PMID 25595907, PMID 26115975, PMID 26483423, PMID 26566796, PMID 27300548, PMID 28293120, PMID 28428441, PMID 29158269, PMID 29373071, PMID 29750983, PMID 29906809, PMID 30742834, PMID 33562091, PMID 7082756