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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03005067 | To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold | PHASE2 | COMPLETED | 171 | — | — | Dec 29, 2016 | Jun 7, 2017 | Jun 19, 2018 | 24 | United States |
| NCT02832362 | Local Nasal Tolerability and Safety Study of 1146A in Healthy Adult Participants | PHASE1 | COMPLETED | 30 | — | — | Jun 11, 2016 | Jul 18, 2016 | Jun 29, 2017 | 1 | Canada |
The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.
The investigators will perform a thorough examination using nasal mucosal grading scale: Grade 0 = No abnormal findings, Grade 1A = focal nasal mucosal irritation (inflammation, erythema or hyperemia), Grade 1B = superficial nasal mucosal erosion, Grade 2 = moderate nasal mucosal erosion
The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
| Arm | Type | Description |
|---|---|---|
| Carbomer 980 (1146A) | EXPERIMENTAL | Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL. |
| Carbomer 980 | EXPERIMENTAL | Participants will be administered test product (nasal spray) containing 0.5% carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). |
| Name | Type | Description |
|---|---|---|
| Carbomer 980 (1146A) | DRUG | Test product containing carbomer 980 gel |
| Placebo | OTHER | Reference product containing vehicle without carbomer 980 gel |
| Carbomer 980 | DRUG | Test product containing 0.5% carbomer 980 gel |
Inclusion Criteria: * Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged between 18 to 75 years inclusive. * Male or female. ...