Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

ABSTRACT: The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

DISEASE(S): Intestinal Diseases,Opioid-induced Constipation,Constipation

PROVIDER: 2031936 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

Project description:The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

| 2049918 | ecrin-mdr-crc

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects with Chronic Non-Malignant Pain.

Project description:Primary objectives: To evaluate the efficacy, safety, and tolerability of oral MOA-728 given daily in a population of subjects with chronic, non-malignant pain who have opioid-induced bowel dysfunction. Primary endpoints: The change from baseline in the number of spontaneous bowel movements (SBMs) per week during the double-blind treatment period.

| 2519808 | ecrin-mdr-crc

Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

Project description:The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

| 2045578 | ecrin-mdr-crc

An Open-Label Study to Evaluate the Long-term Safety of Subcutaneous MOA-728 forTreatment of Opioid-Induced Constipation in Subjects With Nonmalignant PainEstudio abierto para evaluar la seguridad a largo plazo de MOA-728 subcutánea para el tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno

Project description:Primary: The primary objective of the study is to evaluate the long-term safety and tolerability of the subcutaneous formulation of MOA-728 in subjects with opioid-induced constipation who have nonmalignant pain. Primary endpoints: Safety and tolerability will be evaluated by collection of adverse events, laboratory assessments, physical examinations, vital signs measurements, electrocardiograms, Pain Intensity Scale, and the opioid withdrawal scales.

| 2525282 | ecrin-mdr-crc

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study ofSubcutaneous MOA-728 for the Treatment of Opioid-Induced ConstipationEstudio multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, de MOA-728 subcutánea para el tratamiento del estreñimiento inducido por opiáceos

Project description:Primary: To evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with nonmalignant pain who have opioid-induced constipation. Primary endpoints: Two coprimary efficacy endpoints are:1. the proportion of subjects having a RFBM within 4 hours of the first dose administration, and 2. the percentage of injections resulting in any RFBM within 4 hours during the double-blind period.

| 2525287 | ecrin-mdr-crc

Zea mays cultivar:RSQ-728

Project description:Zea mays RSQ-728 Transcriptome

| PRJNA493456 | ENA

Spectrotemporal profiling of ultrasonic vocalizations during neonatal opioid withdrawal reveals a kappa opioid receptor component in female mice

Project description:Opioid use during pregnancy can lead to negative infant health outcomes, including neonatal opioid withdrawal syndrome (NOWS). NOWS comprises gastrointestinal, autonomic nervous system, and neurological dysfunction that manifest during spontaneous withdrawal. Current treatments involve non-pharmacological and pharmacological interventions, however, there is no one standardized approach, in part because of variability in NOWS severity. To effectively model NOWS traits in mice, we used a third trimester-approximate opioid exposure paradigm, where neonatal inbred FVB/NJ and outbred Carworth Farms White (CFW) pups were injected twice-daily with morphine (10-15 mg/kg, s.c.) or saline (0.9%, 20 ul/g, s.c.) from postnatal day (P) one to P14. We observed reduced body weight gain, hypothermia, thermal hyperalgesia, and increased ultrasonic vocalizations (USVs). Neonatal USVs are emitted exclusively in isolation to communicate distress and thus serve as a model behavior for affective states. On P14, we observed altered USV syllable profiles during spontaneous morphine withdrawal, including an increase in Complex 3 syllables in FVB/NJ females (but not males) and in CFW mice of both sexes. Brainstem transcriptomics revealed an upregulation of the kappa opioid receptor (Oprk1), whose activation has previously been shown to contribute to withdrawal-induced dysphoria. Treatment with the kappa opioid receptor (KOR) antagonist, nor-BNI (30 mg/kg, s.c.), significantly reduced USV emission in FVB/NJ females, but not FVB/NJ males during spontaneous morphine withdrawal. Furthermore, treatment with the KOR agonist, U50,488h (0.625 mg/kg, s.c.), was sufficient to increase USV emission on P10 (both sexes) and on P14 (females only) in FVB/NJ mice. Together, these results indicate a female-specific recruitment of the dynorphin/KOR system in neonatal opioid withdrawal symptom severity.

2024-07-09 | GSE271337 | GEO

Chronic opioid treatment arrests neurodevelopment and alters synaptic activity in human midbrain organoids

Project description:Understanding the impact of long-term opioid exposure on the embryonic brain is critical due to the surging number of pregnant mothers with opioid dependency, but has been limited by human brain inaccessibility and cross-species differences in animal models. Here we establish a human midbrain model that uses hiPSC-derived midbrain organoids and apply it to assess cell-type-specific responses to acute and chronic fentanyl treatment and fentanyl withdrawal. Single-cell mRNA sequencing of 25,510 cells from organoids in different treatment groups indicated that chronic fentanyl treatment arrests neuronal subtype specification during early midbrain development and alters synaptic activity and neuron projection. In contrast, acute fentanyl treatment increases dopamine release but does not significantly alter gene expression related to cell lineage development. These results provide the first examination of the effects of opioid exposure on human midbrain development at the single cell level.

2024-03-05 | GSE260711 | GEO

Nitrospinae bacterium SCGC AC-728-G23

Project description:Nitrospinae bacterium SCGC AC-728-G23 Genome sequencing

| PRJNA234994 | ENA

Thaumarchaeota archaeon SCGC AC-728-E05

Project description:Thaumarchaeota archaeon SCGC AC-728-E05 Genome sequencing

| PRJNA235029 | ENA