Dataset Information

Effect of DA-9701, a Novel Prokinetic Agent, on Post-operative Ileus in Rats.

ABSTRACT:

Background/aims

Post-operative ileus (POI) is a common complication of abdominal surgery. DA-9701, an extract of Pharbitis Semen and Corydalis Tuber, is a new prokinetic agent that also alleviates visceral pain. The aim of this study was to investigate whether DA-9701 can ameliorate POI in rats.

Methods

A total of 32 rats were divided into 4 groups: no surgery/no medication (NSNM), no surgery/medication (NSM), surgery/no medication (SNM), and surgery/medication (SM). Gastrointestinal transit (GIT), which is assessed by migration of charcoal, and cumulative stool weight were measured at 24 hours after surgery.

Results

GIT was significantly more delayed in the SNM group than in the other groups (SNM vs NSNM, P < 0.001; SNM vs NSM, P < 0.001; SNM vs SM, P = 0.005). Cumulative stool weight in that group was also lower than in the no surgery groups (SNM vs NSNM, P = 0.007; SNM vs NSM, P = 0.033), and there was no significant difference between the SM group and the no surgery groups (SM vs NSM, P = 0.703; SM vs NSNM, P = 0.347).

Conclusion

DA-9701 can ameliorate POI by reducing delayed GIT and improving defecation in a rat model of POI.

SUBMITTER: Lee SP

PROVIDER: S-EPMC5216641 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Publications

Effect of DA-9701, a Novel Prokinetic Agent, on Post-operative Ileus in Rats.

Lee Sang Pyo SP Lee Oh Young OY Lee Kang Nyeong KN Lee Hang Lak HL Choi Ho Soon HS Yoon Byung Chul BC Jun Dae Won DW

Journal of neurogastroenterology and motility 20170101 1

<h4>Background/aims</h4>Post-operative ileus (POI) is a common complication of abdominal surgery. DA-9701, an extract of Pharbitis Semen and Corydalis Tuber, is a new prokinetic agent that also alleviates visceral pain. The aim of this study was to investigate whether DA-9701 can ameliorate POI in rats.<h4>Methods</h4>A total of 32 rats were divided into 4 groups: no surgery/no medication (NSNM), no surgery/medication (NSM), surgery/no medication (SNM), and surgery/medication (SM). Gastrointesti ...[more]

PMID: 27832682

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Project description:ObjectivesThis study aimed to assess the efficacy of DA-9701 on gastrointestinal symptom-related quality of life in patients with Parkinson's disease on stable dopaminergic medications.MethodsThis multicenter, double-blind, placebo-controlled, phase 4 trial included a total of 144 patients with Parkinson's disease with gastrointestinal dysfunctions based on predefined criteria. Participants were randomized to take either DA-9701 or placebo for 4?weeks, and then both groups were administered DA-9701 for an additional 8?weeks while antiparkinsonian medications were unchanged. The primary outcome measure was gastrointestinal symptoms and related quality-of-life changes assessed on the Korean Nepean dyspepsia index after 4 and 12?weeks of therapy. We also evaluated the impact of DA-9701 therapy on parkinsonian motor symptoms at each time point.ResultsThe gastrointestinal symptom-related quality-of-life score significantly improved in the DA-9701-treated group compared with the placebo-treated group after 4weeks (adjusted P = 0.012 by linear mixed effect model analysis). The overall gastrointestinal symptom and dyspepsia sum scores improved at 12?weeks after intervention in the DA-9701-first treated group (adjusted P = 0.002 and 0.014, respectively) and also in the placebo-first treated group (adjusted P = 0.019 and 0.039) compared with the baseline. Parkinsonian motor severity was not significantly affected by DA-9701 treatment in both groups at 4 and 12?weeks after intervention. There were no drug-related serious adverse events throughout the trial.ConclusionsDA-9701 therapy improved gastrointestinal symptom-related quality of life, and 12?weeks of daily administration can relieve the overall severity of gastrointestinal symptoms in patients with Parkinson's disease without affecting motor symptoms. (Clinical trial identifier: NCT02775591.) © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Project description:BACKGROUND: Stronger prokinetic agents which specifically enhance transit in different parts of the gut are required. R093877 is a novel 5-HT4 agonist prokinetic compound which is chemically related to cisapride but believed to have greater effect on colonic activity. AIMS: To evaluate the effects of R093877 on bowel function, upper and lower gut transit, visceral sensitivity, and sphincter function in healthy volunteers in a double blind, placebo controlled, crossover study. METHODS: The study consisted of five consecutive one week periods: no drug treatment; active drug treatment with either 1 or 2 mg daily or placebo; washout; active drug or placebo; no treatment. Seventeen male subjects maintained a detailed dairy of bowel function for the entire study. Orocaecal transit (breath hydrogen), whole gut transit (radio-opaque markers), and anorectal function were assessed at the end of each of the two treatment periods. Blood testing was performed to confirm compliance and for safety analysis. RESULTS: One subject withdrew from the study due to side effects while on placebo. Eight subjects completed the study on 1 mg and a further eight on 2 mg. Blood testing showed non-compliance in one subject on the 2 mg dose, and he was excluded from analysis of all diary and physiological data. Treatment increased the number of stools per week (placebo versus 1 mg, 7.8 versus 13.6, p = 0.003; placebo versus 2 mg, 8.9 versus 11.3, p = 0.15) and the percentage of loose or watery stools (24.2% versus 61.5%, p < 0.04; 9.9% versus 40.0%, p < 0.02). Stool frequency and consistency reverted to normal immediately after treatment. Treatment shortened orocaecal and whole gut transit in all subjects on both doses. Treatment accelerated orocaecal (76 versus 51 minutes, p = 0.007; 63 versus 47 minutes, p = 0.07) and whole gut (38.2 versus 27.0 hours, p = 0.05; 44.8 versus 24.0 hours, p < 0.04) transit, and decreased the number of retained markers ingested 36 hours previously (4.8 versus 1.8, p = 0.016; 7.0 versus 4.3, p = 0.033). Gut sensitivity to distension and electrical stimulation, and anal manometry, were unchanged. Transient headache occurred in seven subjects on R093877 and one subject had mild elevation of liver aminotransferases which resolved on drug cessation. CONCLUSIONS: R093877 is well tolerated by healthy subjects and has a marked and consistent effect on stool frequency and consistency, and upper gut and colonic transit. It does not affect visceral sensitivity or sphincter function. It holds promise for patients with large bowel symptoms or slow gut transit.

Dataset Information

Effect of DA-9701, a Novel Prokinetic Agent, on Post-operative Ileus in Rats.

Background/aims

Methods

Results

Conclusion

Publications

Effect of DA-9701, a Novel Prokinetic Agent, on Post-operative Ileus in Rats.

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