Postoperative IleusPhase 3NCT01863407
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
A Phase 3 study testing DAM and Normal Saline in people with Postoperative Ileus, run by Beijing Bozhiyin T&S Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- DAM and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Drug Clinical Research, Shanghai University of Chinese Medicine
Shanghai, Shanghai Municipality, 201203
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Ileus
- Being tested
- DAM, Normal Saline
- Keywords
- Ileus, Intestinal Obstruction, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Medical subject headings
- Ileus, Intestinal Obstruction, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAMDrug
Also called Dexamethasone-Allantoin-Metronidazole (DAM) Solution
composed of dexamethasone, allantoin and metronidazole
Normal SalineDrug
Also called NS
Normal Saline 250ml
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7d
Secondary outcomes (5)
Time to ready for discharge
Measured: 7 days
Time to the first flatus
Measured: 7 days
Comparison between the 2 groups of analgesics (morphine) dose
Measured: 7 days
peritoneal exudate volume of 72 hours after operation
Measured: 3 days
C reactive protein changes from baseline
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Bozhiyin T&S Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying-jiang Ye, professor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863407
- Sponsor's protocol ID
- BZY 001
- Status last verified
- May 2013
- First submitted
- 23 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01863407
- Acronym / sponsor ID
- BZY 001
- Conditions
- Postoperative Ileus
- Keywords
- Ileus, Intestinal Obstruction, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Beijing Bozhiyin T&S Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAM Solution | Experimental | Drug: DAMPreheated 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 |
| Normal Saline | Placebo comparator | Drug: Normal SalinePreheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAMAlso: Dexamethasone-Allantoin-Metronidazole (DAM) Solutioncomposed of dexamethasone, allantoin and metronidazole | Drug | DAM Solution |
| Normal SalineAlso: NSNormal Saline 250ml | Drug | Normal Saline |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-jiang Ye, professor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DAM and Normal Saline in people with Postoperative Ileus, run by Beijing Bozhiyin T&S Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing-shan Zheng, professor (13817078595, qingshan.zheng@drugchina.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.