Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clonidine · 1 trial · 1 indication
Pain score AREA UNDER THE CURVE (AUC), which is a calculated area under curve using the trapezoidal rule, where pain scores measured from 0 (no pain) to 10 (worst imaginable pain) are on the y axis, and time is on the x axis (pain scores were measured at 5 minutes, 10 minutes,15 minutes, 30 minutes after epidural initiation for the primary outcome assessment). The scale for AUC is not 0-10 but rather is completely dependent upon the area generated under the curve created by pain scores for the first 30 minutes of epidural analgesia (primary outcome time frame): in this case, the scale is 0-250 pain units\*minute, given maximum pain score possibility of 10 and time period of 30 minutes. The units of AUC are the units of Y axis times units of X axis, in this case, pain score units \* minutes. Pain AUC was compared between Fentanyl, Clonidine and Dexmedetomidine groups.
| Arm | Type | Description |
|---|---|---|
| Clonidine | EXPERIMENTAL | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg |
| Dexmedetomidine | EXPERIMENTAL | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg |
| Ropivacaine + Fentanyl | ACTIVE_COMPARATOR | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg |
| Name | Type | Description |
|---|---|---|
| Clonidine | DRUG | Clonidine belongs to the drug classification of antihypertensives |
| Dexmedetomidine | DRUG | Dexmedetomidine belongs to the drug classification of sedatives |
| Fentanyl | DRUG | Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care |
| Ropivacaine | DRUG | Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care |
Pregnant minors were not enrolled in this trial. Inclusion Criteria: * Pregnant women greater than 18 years of age * American Society of Anesthesiologists (ASA) Physical Status 2 or 3 * Term pregnancy (greater than 37 gestational weeks) * Planning epidural labor analgesia * Singleton pregnancy * V...
Clonidine is being studied for use in pregnancy related conditions, specifically as an adjunct for labor epidural analgesia. It is a small molecule being developed by Grace Therapeutics, Inc. The drug is currently in Phase 2 clinical development and remains investigational, meaning it has not been approved for this use.
Clonidine is a small molecule that acts as an alpha-2 adrenergic agonist. It works by stimulating alpha-2 adrenergic receptors, which can produce analgesic and sedative effects. In the context of labor epidural analgesia, it is being evaluated as an adjunct to enhance pain relief during childbirth.
Clonidine is being developed by Grace Therapeutics, Inc., a biopharmaceutical company. The company's ticker symbol is GRCE. Grace Therapeutics is conducting clinical research to evaluate the effectiveness of Clonidine as an adjunct for labor epidural analgesia in pregnancy related conditions.
Clonidine is in Phase 2 clinical development for pregnancy related conditions. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being studied for its effectiveness as an adjunct for labor epidural analgesia.
Clonidine has been studied in a Phase 2 clinical trial with the identifier NCT05487196. The trial, titled "Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia," was completed in the United States. It enrolled 88 female participants aged 18 years and older, including healthy volunteers.
Clonidine is not the same as Dexmedetomidine or Fentanyl. In the clinical trial NCT05487196, Clonidine was compared with Dexmedetomidine and Fentanyl as adjuncts for labor epidural analgesia. Each is a distinct medication with different pharmacological properties, and the trial evaluated their relative effectiveness.