Approval Probability
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Also known as Entereg
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 used to manage opioid-induced postoperative bowel dysfunction and postoperative ileus, conditions in which opioid pain medicines slow or stop bowel function after surgery. It has also been studied in patients with ovarian, fallopian tube, and peritoneal cancer undergoing surgery. It is a small molecule developed by Merck & Company, Inc.
Alvimopan targets OPRM1, the mu-opioid receptor, and acts as an antagonist. By blocking this receptor in the gastrointestinal tract, it counteracts the constipating and bowel-slowing effects of opioid pain medications while those drugs continue to provide pain relief centrally. This mechanism underlies its study in postoperative ileus and bowel dysfunction.
Alvimopan is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 3 clinical program evaluating the drug in postoperative ileus and in gynecologic cancer surgery patients.
Alvimopan has been studied in Phase 3 clinical development. Four Phase 3 trials are recorded, all of which are completed, with no active trials currently listed. The program enrolled a total of 2,287 participants across randomized, double-blind, placebo-controlled studies.
Alvimopan has been evaluated in four completed Phase 3 trials: NCT01704651 in ovarian, fallopian tube, and peritoneal cancer; and NCT00388479, NCT00388401, and NCT00388258 in postoperative ileus. The ileus trials enrolled 666, 510, and 451 participants respectively, and all four studies were randomized, double-blind, and placebo-controlled.