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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01863407
Other study ID # BZY 001
Secondary ID
Status Recruiting
Phase Phase 3
First received May 23, 2013
Last updated May 28, 2013
Start date April 2013
Est. completion date November 2014

Study information

Verified date May 2013
Source Beijing Bozhiyin T&S Co., Ltd.
Contact Qing-shan Zheng, professor
Phone 13817078595
Email qingshan.zheng@drugchina.net
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
DAM
composed of dexamethasone, allantoin and metronidazole
Normal Saline
Normal Saline 250ml

Locations

Country Name City State
China Center for Drug Clinical Research, Shanghai University of Chinese Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Beijing Bozhiyin T&S Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 7d No
Secondary Time to ready for discharge 7 days No
Secondary Time to the first flatus 7 days No
Secondary Comparison between the 2 groups of analgesics (morphine) dose 7 days No
Secondary peritoneal exudate volume of 72 hours after operation 3 days No
Secondary C reactive protein changes from baseline 7 days No
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