Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alvimopan · 10 trials · 7 indications
Length of stay = date/time of hospital dismissal - date/time of end of surgery
| Arm | Type | Description |
|---|---|---|
| Alvimopan | EXPERIMENTAL | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
| Placebo | PLACEBO_COMPARATOR | Perioperative administration of placebo, at same dosing interval as study drug. |
| Alvimopan 0.5 mg Twice Daily (BID) | EXPERIMENTAL | 0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months. |
| Alvimopan 0.5 mg once daily | EXPERIMENTAL | - |
| alvimopan 0.5 mg twice daily | EXPERIMENTAL | - |
| Alvimopan 1 mg Once Daily (QD) | EXPERIMENTAL | Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks. |
| Alvimopan 1 mg Twice Daily (BID) | EXPERIMENTAL | Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening. |
| Name | Type | Description |
|---|---|---|
| Alvimopan | DRUG | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. |
| Placebo | DRUG | Perioperative administration of placebo, at same dosing interval as study drug. |
| Alviompan | DRUG | 0.5 mg BID |
Inclusion criteria: * Females at least 18 years of age * Have an American Society of Anesthesiologists (ASA) Score of I to III * Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer * Are scheduled to have their nasogastric tube removed before the...
Alvimopan is an investigational small molecule being studied for the treatment of bowel dysfunction, ileus, constipation, ovarian cancer, and cancer. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.
Alvimopan is a small molecule that targets the mu-opioid receptor. It is designed to block the effects of opioids on the gastrointestinal tract, which can help relieve opioid-induced bowel dysfunction and constipation.
Alvimopan is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for gastrointestinal conditions.
Alvimopan is in Phase 3 clinical development. It has completed four clinical trials, all of which were randomized, double-blind, and placebo-controlled. The drug is still investigational and has not been approved by regulatory authorities.
Alvimopan has completed four clinical trials, including NCT00135577, NCT00241722, NCT00256932, and NCT00259922. These trials evaluated the drug for opioid-induced bowel dysfunction and constipation in patients with cancer and non-cancer pain, with a total enrollment of 2,287 participants.
Alvimopan is also known by the brand name Entereg. It is being studied for gastrointestinal conditions such as bowel dysfunction and constipation, and is currently in Phase 3 development by Merck & Company, Inc.