NCT01863407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

May 23, 2013

Last Update Submit

May 28, 2013

Conditions

Postoperative Ileus

Keywords

IleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Time to ready for discharge

    7 days

  • Time to the first flatus

    7 days

  • Comparison between the 2 groups of analgesics (morphine) dose

    7 days

  • peritoneal exudate volume of 72 hours after operation

    3 days

  • C reactive protein changes from baseline

    7 days

Study Arms (2)

DAM Solution

EXPERIMENTAL

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

Normal Saline

PLACEBO COMPARATOR

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

Interventions

DAMDRUG

composed of dexamethasone, allantoin and metronidazole

Also known as: Dexamethasone-Allantoin-Metronidazole (DAM) Solution
DAM Solution
Normal SalineDRUG

Normal Saline 250ml

Also known as: NS
Normal Saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Drug Clinical Research, Shanghai University of Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

MeSH Terms

Conditions

IleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Interventions

SolutionsSaline Solution

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Study Officials

  • Ying-jiang Ye, professor

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing-shan Zheng, professor

CONTACT

13817078595qingshan.zheng@drugchina.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 29, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

CN(1)