AzTrials
AzTrials

Functional ConstipationPhase 1/2NCT01139216

Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation

A Phase 1/2 study testing Daikenchuto (TU-100) in people with Functional Constipation and Gastric Emptying, run by Tsumura USA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Daikenchuto (TU-100)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
Aug 2010to Nov 2012
Phase
Phase 1/2
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 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet Rome III criteria for functional constipation
  • Willing and able to provide written informed consent
  • Females, not pregnant or not breast-feeding
  • Females of childbearing potential must use an acceptable form of contraception during the study and for 30 days after the last dose. Acceptable methods include surgical sterilization, hormonal contraceptives (such as oral contraceptives, Depo-Provera, Nuva Ring, condoms used with a spermicide, an IUD or abstinence.
  • Females are not considered to be of childbearing potential if they are postmenopausal for at least two years or have been surgically sterilized.
  • Ages 18 to 65 years old inclusive
Show all 11Show fewer
  • A body mass index (BMI) between 18 and 40 kg/m2 inclusive
  • A negative urine drug screen at Visit 1
  • Normal or not clinically significant laboratory results as reviewed by the study physicians
  • A normal rectal exam result on file within the past 2 years or performed at Visit 1 in order to exclude the possibility of an evacuation disorder. Examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis muscles.
  • Do not have sufficient criteria for irritable bowel syndrome (IBS)

Who cannot join

  • Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders other than constipation.
  • Taking any medication that in the opinion of the principal investigator has a potential to alter GI transit. This includes but is not limited to osmotic or stimulant laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, selective norepinephrine reuptake inhibitors (SNRIs), opiates, GABAergic agents and benzodiazepines.
  • Note: Tricyclic antidepressants are permissible at doses equal to or less than 25 mg daily; selective serotonin reuptake inhibitor (SSRI) antidepressants are permissible at low, stable doses. Analgesics such as Tylenol, ibuprofen, naproxen and aspirin are permissible. All medications shall be reviewed by the principal investigator on a case by case basis.
  • Rescue medications: Rescue medications shall be reviewed and approved as necessary for exacerbation of constipation as the study medication treatment period is lengthy, about 28 days total. The patient will contact the study staff to request review and approval of the use of a rescue medication by the principal investigator. The use of the rescue medication will be documented by the patient in the bowel pattern diary. Rescue medications are not allowed within 7 days of the abbreviated baseline or the full transit scintigraphy to ensure data integrity.
  • Clinical evidence, including but not limited to a clinically significant abnormal physical exam or laboratory test result or a past event documented in the past medical record, or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the principal investigator. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for evaluation.
  • Patients who are considered to be alcoholics not in remission or known substance abusers.
Show all 10Show fewer
  • Patients who have participated in another clinical study in the past 30 days.
  • Patients who have a history of allergic reactions to egg, ginseng, ginger or Sichuan pepper
  • Patients who are clinically lactose intolerant
  • Patients must agree to avoid alcohol during the days of Visits 5, 6 and 7 to avoid corrupting the data from the anorectal manometry and rectal barostat tests.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic, Rochester Methodist CRU

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Effect of DAIKENCHUTO (TU-100), a Gastrointestinal Nerve Modulator, on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Female Patients With Functional Constipation

The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo.

Being tested
Daikenchuto (TU-100), Placebo
Keywords
Digestive system diseases, Gastrointestinal diseases, Intestinal diseases, Colonic inertia
Medical subject headings
Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daikenchuto (TU-100)Drug

    Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

  • Daikenchuto (TU-100)Drug

    Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

  • PlaceboDrug

    Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

Study groups in NCT01139216
Study groupRoleWhat they receive
Daikenchuto (TU-100) 7.5g/dayExperimentalDaikenchuto (TU-100) 2.5g TID (7.5g/day)
Receives: Drug: Daikenchuto (TU-100)
Daikenchuto (TU-100) 15g/dayExperimentalDaikenchuto (TU-100) 5g TID (15g/day)
Receives: Drug: Daikenchuto (TU-100)
PlaceboPlacebo comparatorPlacebo TID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colonic geometric center at 24 hours measured by scintigraphy

    Measured: Up to 48 hours

  2. T1/2 of ascending colon emptying as measured by scintigraphy

    Measured: Up to 48 hours

Secondary outcomes (11)

  1. Colonic geometric center at 4 hours and 48 hours

    Measured: Up to 48 hours

  2. Colonic filling at 6 hours

    Measured: Up to 48 hours

  3. t1/2 of gastric emptying of solid

    Measured: Up to 48 hours

  4. Rectal Compliance Pr1/2

    Measured: Up to 3 hours

  5. Rectal sensation thresholds (gas, urgency to defecate, and pain)

    Measured: Up to 3 hours

  6. Anal sphincter pressure at rest

    Measured: Up to 3 hours

  7. Anal sphincter pressure during squeeze

    Measured: Up to 3 hours

  8. Recto-anal pressure difference during straining to simulate defecation

    Measured: Up to 3 hours

  9. Stool frequency

    Measured: 6 weeks

  10. Stool consistency

    Measured: 6 weeks

  11. PAC-QOL (Patient Assessment of Constipation Quality of Life) score

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01139216
Sponsor's protocol ID
TU100CPT2
Status last verified
Jan 2013
First submitted
3 Jun 2010
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Iturrino J, Camilleri M, Wong BS, Linker Nord SJ, Burton D, Zinsmeister AR. Randomised clinical trial: the effects of daikenchuto, TU-100, on gastrointestinal and colonic transit, anorectal and bowel function in female patients with functional constipation. Aliment Pharmacol Ther. 2013 Apr;37(8):776-85. doi: 10.1111/apt.12264. Epub 2013 Mar 4.

    PubMed 23451764

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Daikenchuto (TU-100) in people with Functional Constipation and Gastric Emptying, 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 11 inclusion and 10 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 14 Jan 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. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Colonic geometric center at 24 hours measured by scintigraphy (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01139216, which also lists 1 linked publication.

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 14 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in