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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Beijing Bozhiyin T&S Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01863407
First received: May 23, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863407

Contacts
Contact: Qing-shan Zheng, professor 13817078595 qingshan.zheng@drugchina.net

Locations
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.
Investigators
Principal Investigator: Ying-jiang Ye, professor The people's hospital of Beijing university
  More Information

No publications provided

Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov 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.:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Additional relevant MeSH terms:
Intestinal Obstruction
Ileus
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Allantoin
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Metronidazole
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014