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

• ClinicalTrials.gov Identifier: NCT01863407
• Recruitment Status: Unknown
• First Posted: May 29, 2013
• Last Update Posted: May 29, 2013
• Sponsor: Beijing Bozhiyin T&S Co., Ltd.
• Information provided by (Responsible Party): Beijing Bozhiyin T&S Co., Ltd.

Tracking Information

• First Submitted Date: May 23, 2013
• First Posted Date: May 29, 2013
• Last Update Posted Date: May 29, 2013
• Study Start Date: April 2013
• Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 28, 2013): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 28, 2013)

• Time to ready for discharge [ Time Frame: 7 days ]
• Time to the first flatus [ Time Frame: 7 days ]
• Comparison between the 2 groups of analgesics (morphine) dose [ Time Frame: 7 days ]
• peritoneal exudate volume of 72 hours after operation [ Time Frame: 3 days ]
• C reactive protein changes from baseline [ Time Frame: 7 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Postoperative Ileus

Intervention

• Drug: DAM
  composed of dexamethasone, allantoin and metronidazole
  Other Name: Dexamethasone-Allantoin-Metronidazole (DAM) Solution
• Drug: Normal Saline
  Normal Saline 250ml
  Other Name: NS

Study Arms

• 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
  Intervention: Drug: DAM
• 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
  Intervention: Drug: Normal Saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 28, 2013): 480
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2014
• Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01863407
• Other Study ID Numbers: BZY 001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Beijing Bozhiyin T&S Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ying-jiang Ye, professor; Peking University People's Hospital

• PRS Account: Beijing Bozhiyin T&S Co., Ltd.
• Verification Date: May 2013