Trial · NCT07905105
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | From trial drug administration through Day 7 | |
| Primary | Sum of Pain Intensity Differences (SPID) Over 2 Hours (SPID2) in Dental Pain Participants | From pre-dose to 2 hours post-dose | SPID2 is the time-weighted SPID over 0-2 hours after receiving medication, derived from postoperative dental pain assessed on a 0-10 numerical rating scale (NRS). NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Time to Cmax (Tmax) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Area Under the Concentration-time Curve (AUC) From 0 to Last Measurable Concentration (AUC0-t) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | AUC From 0 to Infinity (AUC0-inf) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Elimination Rate Constant (Kel) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Apparent total body clearance (CL) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Total Volume of Distribution (Vss) of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Elimination Half-life (T1/2) of CYT-1010 of CYT-1010 | Pre-dose through 8 hours post-dose | |
| Secondary | Oxygen (O2) Saturation AUC | Pre-dose through 8 hours post-dose | |
| Secondary | Transcutaneous Partial Pressure of Carbon Dioxide (pCO2) AUC | Pre-dose through 8 hours post-dose | |
| Secondary | Respiratory rate AUC | Pre-dose through 8 hours post-dose | |
| Secondary | SPID | Pre-dose through Day 7 post-dose | SPID at other times is the time-weighted Summed Pain Intensity Difference over specified time intervals after receiving medication, derived from postoperative dental pain assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity. |
| Secondary | NRS Pain Intensity Scores | Pre-dose through Day 7 post-dose | NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity. |
| Secondary | Median Time to Confirmed Perceptible Pain Relief | From trial drug administration through 8 hours post-dose | Time to confirmed perceptible and meaningful pain relief is measured with the two stopwatch method, with one stopwatch to note first perceptible pain relief and the other stopwatch to note first time to meaningful pain relief. |
| Secondary | Time to First Use of Rescue Medication | From trial drug administration through 8 hours post-dose | The duration of analgesia generally is defined by the median time to a request for rescue medication. The median time to the first use of rescue medication will be captured from administration of trial medication to first administration of rescue medication. |
| Secondary | Total Dose of Rescue Medication Consumed | From trial drug administration through 8 hours post-dose | |
| Secondary | Participant Global Assessment at 3, 8 and 24 hours Post-dose | At 3, 8, and 24 hours post-dose | The participant will assess his/her global status of pain relief at designated time periods according to a 5-point categorical scale. The assessment should be based on the following question: "How would you rate the trial drug you were administered for pain relief?" with available Likert (word) scores translated to numerical scores as follows: Poor = 0, Fair = 1, Good = 2, Very Good = 3, or Excellent = 4. Higher scores indicate a greater level of pain relief. |
| Secondary | Nurse-observer's Assessment of Sedation Score | Pre-dose through 24 hours post-dose | Nurse-observer's sedation score will be assessed using the Ramsay Sedation Scale (RSS), ranging from 1 to 6, where 1: indicates the participant is anxious, agitated, or restless; 2: indicates the participant is cooperative, oriented, and tranquil; 3: indicates the participant responds to commands only; 4: indicates a brisk response to a light glabellar tap or loud auditory stimulus; 5: indicates a sluggish response to a light glabellar tap or loud auditory stimulus; and 6: indicates no response to these stimuli. Higher scores indicate a greater level of sedation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07905105/registered