Achievements
Phase I Studies
| Study Type | No. of Protocols |
|---|---|
| Single Dose | 526 |
| Multiple Dose | 346 |
| BE | 286 |
| Patch Test | 24 |
| Others | 7 |
| TOTAL | 1,189 |
(Dec 1, 2011)
Phase II - IV
| Study Type | No. of Protocols |
|---|---|
| Early Phase II | 77 |
| Late Phase II | 86 |
| Phase III | 204 |
| PK / PD | 28 |
| Phase IV, Others | 8 |
| TOTAL | 403 |
(Dec 1, 2011)
Achievements by Indications since 1995
| Therapeutic Areas & Indications | No. of Protocols | No. of Subjects | |
|---|---|---|---|
| Lifestyle Related Diseas | Diabetes | 91 | 2,286 |
| Impaired Glucose Tolerance | 4 | 177 | |
| Obesity | 7 | 160 | |
| Hypertension | 72 | 3,586 | |
| Dyslipidemia | 20 | 677 | |
| Hyperuricemia | 6 | 125 | |
| Otolaryngology | Seasonal Allergic Rhinitis | 28 | 4,751 |
| Perennial Allergic Rhinitis | 6 | 1,060 | |
| Ophthalmology | Glaucoma | 28 | 873 |
| Dry Eye | 14 | 364 | |
| Conjunctivitis/Keratitis | 13 | 907 | |
| Corneal Epithelium Disorder | 1 | 32 | |
| Contact Lens | 2 | 113 | |
| Respiratory | Bronchial Asthma/Acute Upper Respiratory Inflammation | 12 | 158 |
| Urology | Incontinence/Over Bladder/Dysuria | 9 | 302 |
| Psychiatry | Insomnia | 6 | 54 |
| Other Internal Medicine | Crohn's Disease | 3 | 18 |
| Cancer Pain | 8 | 56 | |
| Hyperparathyroidism | 5 | 64 | |
| Dialysis | 33 | 367 | |
| Plastic Surgery | Knee Osteoarthritis/Low Back Pain | 4 | 448 |
| Osteoporosis | 3 | 54 | |
| Others | Others | 28 | 828 |
| TOTAL | 403 | 17,460 | |
(Dec 1, 2011)
PK/PD Stuides since 2008
| Indications | No. of Subjects /Protcols (including other sites) | Actual No. of Subjects Enrolled /planned | Entry Period (within) | Study Site | |
|---|---|---|---|---|---|
| Jul 2010 | Nocturia | 100 | 5 / 5 4 / 5 (by add-on contract) | 1.5 months 1 week | Koganeibashi Sakura (Tokyo) |
| Jun 2010 | Diabetes | 60 | 60 / 60 4 / 10 (by add-on contract) | 4 months 1 week | OCROM Clinic (Osaka) |
| Mar 2010 | Hepatitis C | 20 | 4 / 6 1 / 1 | 3 months － | OCROM Clinic (Osaka) ToCROM Clinic (Tokyo) |
| Feb 2010 | Diabetes | 90 | 31 / 36 18 / 30 | 2 months 1.5 months | OCROM Clinic (Osaka) Koganeibashi Sakura (Tokyo) |
| Sept 2009 | Dyslipidemia | 120 | 50 / 60 60 / 60 | 2 months 3 months | OCROM Clinic (Osaka) ToCROM Clinic (Tokyo) |
| Apr 2009 | Hypertriglyceridemia | 30 | 30 / 30 | 4 months | OCROM Clinic (Osaka) |
| Apr 2009 | Diabetes | 80 | 25 / 25 15 / 15 | 4 months 3 months | OCROM Clinic (Osaka) Koganeibashi Sakura (Tokyo) |
| Oct 2008 | Diabetes | 20 | 10 / 10 | 2 months | OCROM Clinic (Osaka) |
| Sept 2008 | Glaucoma | 21 | 8 / 9 | 2.5 months | OPHAC Hospital (Osaka) |
| Aug 2008 | Diabetes | 60 | 13 / 15 9 / 15 | 3 months 2 months | OCROM Clinic (Osaka) ToCROM Clinic (Tokyo) |
| Aug 2008 | Allergic Rhinitis | 36 | 30 / 36 | 1 months | Koganeibashi Sakura (Tokyo) |
| Jun 2008 | Hypertension | 14 | 14 / 14 | 1 week | OCROM Clinic (Osaka) |
| Jan 2008 | Diabetes | 66 | 14 / 14 | 2 months | OCROM Clinic (Osaka) |
| Jan 2008 | Hypertension | 42 | 10 / 18 | 1 week | OCROM Clinic (Osaka) |
(Dec 1, 2011)
GCP Inspection Record since 2001
| Inspection Date | Site of Inspection | Study Type | Inspector |
|---|---|---|---|
| Sept 2011 | TOCROM Clinic (Tokyo) | PIII | PMDA |
| May 2011 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Feb 2011 | OPHAC Hospital (Osaka) | PIII | PMDA |
| Jan 2011 | OPHAC Hospital (Osaka) | PIII | PMDA |
| Nov 2010 | TOCROM Clinic (Tokyo) | PIII | FDA |
| Nov 2010 | OCROM Clinic (Osaka) | PIII | FDA |
| Oct 2010 | OPHAC Hospital (Osaka) | PI | PMDA |
| Dec 2009 | OPHAC Hospital (Osaka) | PIIa | PMDA |
| June 2009 | OCROM Clinic (Osaka) | PIV | PMDA |
| May 2008 | An affiliated clinic | PIIb | PMDA |
| April 2008 | OPHAC Hospital (Osaka) | PI | PMDA |
| Sept 2007 | TOCROM Clinic (Tokyo) | PIII | PMDA |
| Feb 2007 | OPHAC Hospital (Osaka) | PI | PMDA |
| Mar 2004 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Feb 2004 | An affiliated clinic | PIII | PMDA |
| Aug 2003 | An affiliated clinic | PIIb | PMDA |
| Aug 2003 | An affiliated clinic | PIIb | PMDA |
| July 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Jan 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Nov 2002 | An affiliated clinic | PIIb | PMDA |
| Sept 2002 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Oct 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Oct 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Sept 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Sept 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| July 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
(Dec 1, 2011)