Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects.

ABSTRACT: Primary objectives: To identify at least one alvimopan treatment regimen that improves spontaneous complete bowel movement (SCBM) frequency compared to placebo while maintaining an acceptable tolerability profile. Primary endpoints: Changes in weekly spontaneous complete bowel movement (SCBM) frequency during the 3-week Treatment Period.

DISEASE(S): Opioid-induced Bowel Dysfunction

PROVIDER: 2517533 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects with Chronic Pain of Non-Malignant Origin

Project description:Primary objectives: To identify at least one orally-dosed alvimopan treatment regimen that improves spontaneous bowel movement (SBM) frequency compared to placebo while maintaining an acceptable tolerability profile. Primary endpoints: The primary endpoint is the changes in weekly spontaneous bowel movement frequency during the first 3 weeks of the 6-week Treatment Period

| 2515727 | ecrin-mdr-crc

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain

Project description:Primary objectives: To compare alvimopan with placebo for efficacy in the treatment of OBD Primary endpoints: Proportion of subjects responding on spontaneous BM frequency

| 2517462 | ecrin-mdr-crc

Project description:Primary objectives: To compare alvimopan with placebo for efficacy in the treatment of OBD Primary endpoints: Proportion of subjects responding on spontaneous BM frequency

| 2517463 | ecrin-mdr-crc

Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Project description:Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

| 2023988 | ecrin-mdr-crc

A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects.

Project description:Primary objectives: To compare the safety among the treatment regimens, while offering continued access to blinded investigational product to subjects who have completed a prior GSK alvimopan OBD study in cancer pain subjects. Primary endpoints: Incidence of reported adverse events, including serious adverse events.

| 2515918 | ecrin-mdr-crc

Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Project description:Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

| 2023761 | ecrin-mdr-crc

Management of postoperative ileus: focus on alvimopan.

Project description:Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication. Ileus causes a variety of symptoms including bloating, pain, nausea, and vomiting, but particularly delays tolerance of oral diet and liquids. Thus POI is a primary determinant of hospital stay after surgery. 'Fast-track' recovery protocols, opioid sparing analgesia, and laparoscopic surgery reduce but do not eliminate postoperative ileus. Alvimopan is a mu opioid receptor antagonist that blocks the effects of opioids on the intestine, while not interfering with their centrally mediated analgesic effect. Several large randomized clinical trials have demonstrated that alvimopan accelerates the return of gastrointestinal function after surgery and subsequent hospital discharge by approximately 20 hours after elective open segmental colectomy. However, it has not been tested in patients undergoing laparoscopic surgery and is less effective in patients receiving nonsteroidal anti-inflammatory agents in a narcotic sparing postoperative pain control regimen. Safety concerns seen with chronic low dose administration of alvimopan for opioid bowel dysfunction have not been noted with its acute use for POI.

| S-EPMC2621409 | biostudies-literature

Project description:Spontaneous mutation frequency in respiratory deficient yeast

| PRJNA632985 | ENA

Transcription profiling of tumors from the melanoblastoma bearing Libechov Minipig (MeLiM) model at 8 to 91 days after birth

Project description:Spontaneous regression is a well defined phenomenon commonly observed in human melanoma in its partial histopathological form but sporadically in its complete expression. Molecular mechanisms which might be involved in spontaneous regression are poorly understood so far. The Melanoblastoma bearing Libechov Minipig (MeLiM) model exhibits cutaneous melanomas which appear in utero or shortly after birth. These lesions are clinically and histologically highly comparable to their human counterparts. Nevertheless, in swine most of the highly invasive melanomas undergo complete spontaneous regression. Induction of regression is expressed by clinical features including changes in color, drying aspect and decrease in size; histologically we observed infiltration of histiocyte-like cells, fibrosis and lymphocytic infiltrate later. To characterize the regression phase on a transciptomic level, we performed time dependent gene expression profiling using the MeLiM model and porcine Affymetrix microarrays. We collected 5 different tumors of 5 siblings at 5 timepoints, from day 8 to day 91 after birth. After statistical analysis and reannotation of the 25 porcine microarrays we were able to identify 1411 genes regulated during regression. K-means clustering and subsequent functional clustering of these genes via Ingenuity Pathway analysis revealed significant pathways playing a role in melanoma regression. Genes involved in cell cycle, apoptosis, cellular movement, melanocyte-differentiation and pigmentation as well as genes of the immune reponse seem to be potential mediators of melanoma regression.

2008-09-10 | E-MEXP-1152 | biostudies-arrayexpress

Bowel miRNA expression profiles of infants with gastrointestinal conditions

Project description:We have employed miRNA microarray expression profiling to identify miRNA differentially expressed in neonatal bowel tissues with different gastrointestinal conditions. Bowel tissues were collected from infants who underwent surgery treatment for necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP). Infants with other non-inflammatory, congenital intestinal conditions were employed as the Surgical-Control. Differential miRNA microarray analysis was performed.

2015-08-24 | E-GEOD-68054 | biostudies-arrayexpress

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data