15 completed, 2 unknown. 9 Not applicable, 3 Phase 2, 3 Phase 3, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 9 | Completed 8, Unknown 1 |
| Phase 2 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 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 |
|---|---|---|---|---|---|---|
| Evaluation Of The Effect Of L. Casei DG® On Vitamin D Absorption In Patients Under Vitamin D Supplementation. L. casei DG® (Lactobacillus paracasei CNCM I-1572), placebo - Vitamin D Deficiency | Not applicable | Unknown | SOFAR S.p.A. | 46 | 2023-06-01 | 2023-04-12 |
| Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers Beclomethasone dipropionate - Healthy Adult Male Volunteers | Phase 1 | Completed | SOFAR S.p.A. | 28 | 2021-10-22 | 2022-05-04 |
| Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet, Placebo 1100 mg, identically-looking melt in mouth tablet - Gastro Esophageal Reflux | Not applicable | Completed | SOFAR S.p.A. | 40 | 2019-11-05 | 2023-04-12 |
| Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease hyaluronic acid with chondroitin + sulphate + magnesium trisilicate, Placebo - Gastro Esophageal Reflux | Not applicable | Completed | SOFAR S.p.A. | 21 | 2018-12-20 | 2022-05-06 |
| L. Casei DG® in Patients With Irritable Bowel Syndrome. L.casei DG, PLACEBO - IBS - Irritable Bowel Syndrome | Not applicable | Completed | SOFAR S.p.A. | 264 | 2017-11-06 | 2022-05-06 |
| Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor GERDOFF® + Omeprazole, Omeprazole - Gastro-oesophageal Reflux Disease | Not applicable | Completed | SOFAR S.p.A. | 72 | 2017-05-05 | 2020-03-31 |
| Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic Bifidobacterium, BB-12® (Bifidolactis Infant), Bifidolactis Infant Placebo - Infantile Colic, Colic, Infantile | Not applicable | Completed | SOFAR S.p.A. | 80 | 2016-11-11 | 2020-01-23 |
| Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC) probiotic (BIfidobacterium, BB-12®), Placebo - Infantile Colic | Not applicable | Completed | Federico II University | 80 | 2016-11-01 | 2019-04-16 |
| Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX Telelap ALF-X - Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis | Phase 2 | Unknown | Catholic University of the Sacred Heart | 50 | 2015-02-01 | 2015-01-14 |
| Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA® Lidocaine Hydrochloride - Wound Healing Disorder | Completed | SOFAR S.p.A. | 78 | 2015-01-27 | 2023-04-12 | |
| Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study Lactobacillus casei DG, Placebo - Irritable Bowel Syndrome | Not applicable | Completed | SOFAR S.p.A. | 44 | 2014-12-01 | 2016-02-02 |
| Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study TELELAP ALF-X Robotic Surgical System - Adnexal Diseases, Uterine Diseases | Not applicable | Completed | SOFAR S.p.A. | 150 | 2013-10-23 | 2017-03-28 |
| Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an "in Vivo" Evaluation of the Molecular Effects on β-catenin Signaling Pathway. Mesalazine - Colorectal Cancer | Phase 2 | Completed | SOFAR S.p.A. | 21 | 2012-10-01 | 2016-12-02 |
| Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study Lactobacillus casei DG - Irritable Bowel Syndrome | Phase 4 | Completed | SOFAR S.p.A. | 10 | 2012-03-01 | 2014-12-02 |
| Mesalazine Therapy in Patients With Irritable Bowel Syndrome Mesalazine, Placebo - Irritable Bowel Syndrome | Phase 3 | Completed | SOFAR S.p.A. | 187 | 2007-12-01 | 2013-07-26 |
| Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares mesalamine, placebo - Diverticular Disease | Phase 3 | Completed | SOFAR S.p.A. | 105 | 2005-10-01 | 2013-09-18 |
| A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome mesalazine, placebo - Irritable Bowel Syndrome | Phase 2 / Phase 3 | Completed | SOFAR S.p.A. | 20 | 2004-09-01 | 2008-10-16 |
Irritable Bowel Syndrome (5) · Gastroesophageal Reflux (3) · Colic (2) · Abdominal Pain (1) · Adnexal Diseases (1) · Colorectal Neoplasms (1) · Diverticular Diseases (1) · Genital Diseases, Female (1) · Neoplasms (1) · Pain (1) · Precancerous Conditions (1) · Uterine Diseases (1) · Vitamin D Deficiency (1)
Mesalamine (4) · Beclomethasone (1) · Lidocaine (1) · Omeprazole (1) · Probiotics (1)
Italy (14) · Belgium (1) · Germany (1) · United Arab Emirates (1)
Giovanni Barbara, MD (2) · Alessandro Repici, MD (1) · Barbara Giovanni, Doctor (1) · Elia Ricci, MD (1) · Federico Buffoli, Doctor (1) · Giorvanni Barbara, MD (1) · Giovanni Monteleone, Professor (1) · Giovanni Scambia, Professor (1) · Jan Tack, Prof. (1) · Marco Romanelli, MD (1) · Roberto Berni Canani, Prof. (1) · Roberto Corinaldesi, MD (1) · Roberto Corinaldesi, Professor (1)
PMID 23225591, PMID 23754545, PMID 24706079, PMID 25225214, PMID 25433265, PMID 25533646, PMID 29881616