search
Back to results

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

Primary Purpose

Postoperative Ileus

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
DAM
Normal Saline
Sponsored by
Beijing Bozhiyin T&S Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Ileus, Intestinal Obstruction, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Drug Clinical Research, Shanghai University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAM Solution

Normal Saline

Arm Description

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

Preheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure

Outcomes

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.

Secondary Outcome Measures

Time to ready for discharge
Time to the first flatus
Comparison between the 2 groups of analgesics (morphine) dose
peritoneal exudate volume of 72 hours after operation
C reactive protein changes from baseline

Full Information

First Posted
May 23, 2013
Last Updated
May 28, 2013
Sponsor
Beijing Bozhiyin T&S Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01863407
Brief Title
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Bozhiyin T&S Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Ileus, Intestinal Obstruction, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAM Solution
Arm Type
Experimental
Arm Description
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
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Preheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure
Intervention Type
Drug
Intervention Name(s)
DAM
Other Intervention Name(s)
Dexamethasone-Allantoin-Metronidazole (DAM) Solution
Intervention Description
composed of dexamethasone, allantoin and metronidazole
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
NS
Intervention Description
Normal Saline 250ml
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time to ready for discharge
Time Frame
7 days
Title
Time to the first flatus
Time Frame
7 days
Title
Comparison between the 2 groups of analgesics (morphine) dose
Time Frame
7 days
Title
peritoneal exudate volume of 72 hours after operation
Time Frame
3 days
Title
C reactive protein changes from baseline
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing-shan Zheng, professor
Phone
13817078595
Email
qingshan.zheng@drugchina.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-jiang Ye, professor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Drug Clinical Research, Shanghai University of Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs