Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by Beijing Bozhiyin T&S Co., Ltd..
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Beijing Bozhiyin T&S Co., Ltd. Identifier:
First received: May 23, 2013
Last updated: May 28, 2013
Last verified: May 2013
This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal operation when compared with a placebo.

Condition Intervention Phase
Postoperative Ileus
Drug: DAM
Drug: Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI) in Subjects Undergoing Abdominal Operation

Resource links provided by NLM:

Further study details as provided by Beijing Bozhiyin T&S Co., Ltd.:

Primary Outcome Measures:
  • Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2. [ Time Frame: 7d ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to ready for discharge [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Time to the first flatus [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of analgesics (morphine) dose [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • peritoneal exudate volume of 72 hours after operation [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • C reactive protein changes from baseline [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAM Solution
Preheated to a temperature level, mixed the DAM Solution 2ml and Normal Saline 250ml, poured into abdominal cavity and infiltrate the operative field before the abdominal closure
Drug: DAM
composed of dexamethasone, allantoin and metronidazole
Other Name: Dexamethasone-Allantoin-Metronidazole (DAM) Solution
Placebo Comparator: Normal Saline
Preheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure
Drug: Normal Saline
Normal Saline 250ml
Other Name: NS

Detailed Description:
Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. This is a randomized, controlled, double-blind study designed to evaluate the tolerability and efficacy of DAM solution for the treatment of POI in patients following abdominal operation. It will be conducted at multiple centers in China. A total of 480 patients will be enrolled in the study. Patient participation in the study will last for up to postoperative day 7 [POD 7] , with follow-up safety assessments to occur 7 days after the operation.The treatment outcome measures include: 1) GI2(Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food). 2) Time to ready for discharge. 3) Time to the first flatus.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are either Male or Female at least 18 years of age;
  • Had an American Society of Anesthesiologists (ASA) Physical Status Score of I-III;
  • Were scheduled to undergo partial small or large BR with primary anastomosis (performed completely by laparotomy); biliary-enteric Roux-en-Y anastomosis surgery;
  • BMI (kg/m^2) index≥15 and ≤30;
  • Understood the procedures, agreed to participate in the study program, and voluntarily signed the informed consent form.

Exclusion Criteria:

  • Had complete bowel obstruction;
  • Were scheduled for a total colectomy;
  • Were scheduled for a ileal pouch-anal anastomosis;
  • Were scheduled for a colostomy, ileostomy;
  • Had a history of gastrectomy, total colectomy, gastric bypass, short bowel syndrome, or multiple previous abdominal surgeries;
  • Had clinically significant laboratory abnormalities on screening(such as: ALT, AST were more than 2 times the upper limit of normal value; Cr is greater than 1.2 times the upper normal limit, according to the center for the study of the normal value range);
  • Applied the intravenous or epidural postoperative analgesia pump;
  • Bowel preparation does not meet the requirements;
  • Were allergy to components of the investigational drug (allantoin, metronidazole, dexamethasone);
  • Had used illicit drugs or had abused alcohol;
  • Had a history of illness, or behavior (e.g., depression, psychosis) that in the opinion of the investigator might confound the results of the study or pose an additional risk in participating in the study;
  • Women who were pregnant, and women who were of childbearing potential and not using method of birth control;
  • Had participated in another clinical drug trial within the last 3 months;
  • Were not agreed to participate the clinical trial by investigators.
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Please refer to this study by its identifier: NCT01863407

Contact: Qing-shan Zheng, professor 13817078595

China, Shanghai
Center for Drug Clinical Research, Shanghai University of Chinese Medicine Recruiting
Shanghai, Shanghai, China, 201203
Sponsors and Collaborators
Beijing Bozhiyin T&S Co., Ltd.
Principal Investigator: Ying-jiang Ye, professor The People’s Hospital of Beijing University
  More Information

Responsible Party: Beijing Bozhiyin T&S Co., Ltd. Identifier: NCT01863407     History of Changes
Other Study ID Numbers: BZY 001 
Study First Received: May 23, 2013
Last Updated: May 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Bozhiyin T&S Co., Ltd.:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Additional relevant MeSH terms:
Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Pharmaceutical Solutions
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiparasitic Agents
Antiprotozoal Agents
Autonomic Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 26, 2016