Postoperative IleusPhase 2NCT00266461
A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
A Phase 2 study testing Daikenchuto Extract Granules (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 1 site in United States.
Trial summary
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Daikenchuto Extract Granules (TU-100)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jan 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, a patient must meet all of the following criteria:
- Is at least 18 years of age;
- Is male or female. Female patients cannot be pregnant or lactating and must be surgically sterile, postmenopausal (no menses for the previous 12 months), or practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implantable contraceptives, tubal ligation, or partner with vasectomy);
- Has been diagnosed with sigmoid carcinoma; ascending, transverse, or descending colon carcinoma; colonic polyps; carcinoid tumors; lymphoma localized to the abdomen; ischemic bowel; toxic megacolon with no perforation; any tumor of the bowel determined to require removal; or diverticulitis;
- Requires laparotomy for large bowel resection. Note: patients who are shifted to laparotomy during laparoscopic surgery are acceptable;
- Is hospitalized for surgery and recovery;
- Has a pre-operative Karnofsky performance status of 80% to 100%; and
- Provides written informed consent prior to participation in the study after full explanations of the study purpose and procedures.
Who cannot join
- In order to participate in this study, a patient must not meet any of the following criteria:
- Has been diagnosed with Crohn's disease, ulcerative colitis, or irritable bowel syndrome. Note: patients with inactive ulcerative colitis who are in stable clinical remission and/or on maintenance therapy to prevent relapse are acceptable;
- Is a pregnant or lactating female;
- Requires a colostomy or any other ostomy device placement;
- Requires emergency surgery or has surgery in the presence of an ongoing infection, including bowel obstruction and perforated bowel;
- Has colorectal cancer with a Dukes Classification score of D;
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- Has diabetic neuropathy;
- Has a history of gastroparesis;
- Has a compromised immune system, either from treatment with corticosteroids or other immunosuppressive agents within 2 weeks of surgery or from immunosuppressive diseases (eg, human immunodeficiency virus); Note: patients on chronic treatment (for at least 3 months) with corticosteroids of up to 10 mg daily of prednisone or equivalent are acceptable if dosing has been stable for at least 2 weeks;
- Has any other serious condition that might adversely affect their safety or ability to participate in this study, such as liver disorders (including alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels greater than 2.5 times the upper limit of normal [ULN]), kidney disorders, heart failure, blood disorders, or metabolic disorders;
- Has a history of any allergic reactions to ginseng, ginger, Zanthoxylum fruit (Sichuan pepper), or maltose;
- Has a history of narcotic drug abuse (especially heroin or opium) or chronic narcotic use for pain management within 2 weeks of surgery;
- Requires anticancer radiation or chemotherapy within 2 weeks of surgery;
- Has a history of laparotomy or laparoscopy other than simple laparoscopic procedures such as cholecystectomy, gynecological procedures, or inguinal hernia repair. Note: a history of laparoscopic fundoplication is exclusive, while a history of appendectomy or hysterectomy is acceptable; patients who have had laparotomy procedures in the past with no history of subsequent small bowel or large bowel obstruction are acceptable;
- Has a history of any type of ileus;
- Has a history of receiving abdominal radiation therapy in addition to subsequent small bowel or large bowel obstruction. Note: a history of radiation therapy with no small bowel or large bowel obstruction is acceptable; a history of pelvic radiation therapy is also acceptable;
- Is unwilling or unable to comply with the procedures described in this protocol or is otherwise unacceptable for enrollment in the opinion of the investigator; and
- Has participated in any other investigational product or device trial within 30 days prior to enrolling in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Controlled, Open-Label Tolerability And Efficacy Study Of TU-100 For The Treatment Of Postoperative Ileus In Patients Undergoing Laparotomy For Large Bowel Resection
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes, inflammatory responses, and the effects of anesthesia and analgesics all playing roles. However, there is no approved pharmacological therapy for the treatment and prevention of POI.
Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue, the classical medical textbook written in ancient China in the third century by Zhang Zhong Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of abdominal pain and a feeling of coldness in the abdomen.
Read more
TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product manufactured in the dosage form of granules by Tsumura \& Co. The current Tsumura product, TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term for the system of traditional medicine that was developed in Japan after being introduced from China in the fourth century) drug in Japan for many years. The drug product proposed for use in the clinical studies is identical to the drug currently sold in Japan. In addition, all three botanical components and maltose syrup powder are considered as food substances and are currently part of the United States food supply.
The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection
Read the detailed description
This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 [POD 10] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
- Conditions
- Postoperative Ileus
- Being tested
- Daikenchuto Extract Granules (TU-100)
- Keywords
- Postoperative Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daikenchuto Extract Granules (TU-100)Drug
| Study group | Role | What they receive |
|---|---|---|
| TU-100 7.5g/day | Experimental | Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. Receives: Drug: Daikenchuto Extract Granules (TU-100) |
| TU-100 15g/day | Experimental | Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. Receives: Drug: Daikenchuto Extract Granules (TU-100) |
| Water | No intervention | Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the tolerability of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection based on the incidence of adverse events (AEs).
Measured: Up to 10 days
Secondary outcomes (3)
To evaluate the safety of TU-100 in the treatment of POI based on an assessment of objective and subjective symptoms and clinical laboratory data
Measured: Up to 10 days
To evaluate the efficacy of TU-100 in the treatment of POI based on the length of time from the end of surgery to gastrointestinal(GI) function recovery and time to discharge order, and
Measured: Up to 10 days
To determine the acceptability of TU-100 to American patients based on the number of discontinuations due to noncompliance and an assessment of taste.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsumura USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shunji Mochida, PhD, Study director, Tsumura USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266461
- Sponsor's protocol ID
- TU100P2T1
- Status last verified
- Jun 2012
- First submitted
- 14 Dec 2005
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label Tolerability And Efficacy Study Of TU-100 For The Treatment Of Postoperative Ileus In Patients Undergoing Laparotomy For Large Bowel Resection
- ClinicalTrials.gov ID
- NCT00266461
- Acronym / sponsor ID
- TU100P2T1
- Conditions
- Postoperative Ileus
- Keywords
- Postoperative Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Dec 2005 (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.
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes, inflammatory responses, and the effects of anesthesia and analgesics all playing roles. However, there is no approved pharmacological therapy for the treatment and prevention of POI.
Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue, the classical medical textbook written in ancient China in the third century by Zhang Zhong Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of abdominal pain and a feeling of coldness in the abdomen.
TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product manufactured in the dosage form of granules by Tsumura \& Co. The current Tsumura product, TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term for the system of traditional medicine that was developed in Japan after being introduced from China in the fourth century) drug in Japan for many years. The drug product proposed for use in the clinical studies is identical to the drug currently sold in Japan. In addition, all three botanical components and maltose syrup powder are considered as food substances and are currently part of the United States food supply.
The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection
Detailed description
This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 [POD 10] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TU-100 7.5g/day | Experimental | Drug: Daikenchuto Extract Granules (TU-100)Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. |
| TU-100 15g/day | Experimental | Drug: Daikenchuto Extract Granules (TU-100)Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. |
| Water | No intervention | –Subjects will be randomized to TU-100 7.5g, 15g, or no active treatment group. Subjects will take a daily dose divided into 3 times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is at least 18 years of age;
- Is male or female. Female patients cannot be pregnant or lactating and must be surgically sterile, postmenopausal (no menses for the previous 12 months), or practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implantable contraceptives, tubal ligation, or partner with vasectomy);
- Has been diagnosed with sigmoid carcinoma; ascending, transverse, or descending colon carcinoma; colonic polyps; carcinoid tumors; lymphoma localized to the abdomen; ischemic bowel; toxic megacolon with no perforation; any tumor of the bowel determined to require removal; or diverticulitis;
- Requires laparotomy for large bowel resection. Note: patients who are shifted to laparotomy during laparoscopic surgery are acceptable;
- Is hospitalized for surgery and recovery;
Key exclusion criteria (18 listed)
- In order to participate in this study, a patient must not meet any of the following criteria:
- Has been diagnosed with Crohn's disease, ulcerative colitis, or irritable bowel syndrome. Note: patients with inactive ulcerative colitis who are in stable clinical remission and/or on maintenance therapy to prevent relapse are acceptable;
- Is a pregnant or lactating female;
- Requires a colostomy or any other ostomy device placement;
- Requires emergency surgery or has surgery in the presence of an ongoing infection, including bowel obstruction and perforated bowel;
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 |
|---|---|---|
| Daikenchuto Extract Granules (TU-100) | Drug | TU-100 15g/day, TU-100 7.5g/day |
Primary outcome
Evaluate the tolerability of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection based on the incidence of adverse events (AEs).
Time frame: Up to 10 days
3 secondary outcomes
To evaluate the safety of TU-100 in the treatment of POI based on an assessment of objective and subjective symptoms and clinical laboratory data
Time frame: Up to 10 days
To evaluate the efficacy of TU-100 in the treatment of POI based on the length of time from the end of surgery to gastrointestinal(GI) function recovery and time to discharge order, and
Time frame: Up to 10 days
To determine the acceptability of TU-100 to American patients based on the number of discontinuations due to noncompliance and an assessment of taste.
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Shunji Mochida, PhD study director
Tsumura USA Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daikenchuto Extract Granules (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 1 site in United States.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 12 Jul 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the tolerability of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection based on the incidence of adverse events (AEs). (time frame: Up to 10 days). 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 12 Jul 2013.