Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05348200 | Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids | PHASE2 | COMPLETED | 304 | — | — | Apr 22, 2022 | May 17, 2023 | Aug 31, 2023 | 16 | United States |
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
| Arm | Type | Description |
|---|---|---|
| Monad 1 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 2 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 3 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (low dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (high dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Name | Type | Description |
|---|---|---|
| Monad 1 | DRUG | Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic. |
| Monad 2 | DRUG | Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid. |
| Monad 3 | DRUG | Single therapy cream containing Halobetasol Propionate (high strength). |
| Combination - CITI-002 (low dose) | DRUG | Combination cream containing Lidocaine and HBP (low) |
| Combination - CITI-002 (high dose) | DRUG | Combination cream containing Lidocaine and HBP (high) |
Inclusion Criteria: * Male or non-pregnant female 18 years of age or older. * Signs written informed consent for the study. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control, or women of childbearing potential (WOCBP) must have a negative Urine Pre...