Functional ConstipationPhase 2NCT01348152
Effect of TU-100 in Patients With Functional Constipation
A Phase 2 study testing DAIKENCHUTO (TU-100) in people with Functional Constipation, run by Tsumura USA at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- DAIKENCHUTO (TU-100)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have severity of constipation in CSI score of 25 to 74 points.
- Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
- Be male or female aged between 18 and 80 years old, inclusive.
- Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
- If a female is of childbearing potential and sexually active:
- She must agree to practice a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, during their participation in the trial and for 4 weeks after receiving the last dose of study drug
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- She must have a negative serum pregnancy test before randomization.
- If a male is sexually active with a female of childbearing potential:
- He must agree to use a double barrier of birth control during the study and for 4 weeks after receiving the last dose of study drug.
- He must not donate sperm during the study and for 4 weeks after receiving the last dose of study drug.
Who cannot join
- Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
- Presence of implanted or portable electro-mechanical medical devices.
- History of gastric bezoar or swallowing disorders.
- History of gastrointestinal surgery within 3 months of screening.
- History of bowel resection.
- Current pregnancy or lactation.
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- History of clinically significant alcohol or drug abuse within a year of screening.
- Have any other condition that might adversely affect capacity to participate in this study, including liver disorders (with serum alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels exceeding 2.5 times the upper limit of normal [ULN]), kidney disorders, heart failure, blood disorders, or metabolic disorders.
- Be diagnosed with cancer, ulcerative colitis, Crohn's disease, diverticulitis, scleroderma, Hirschsprung's disease, Chagas' disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin-dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation of TU-100.
- Be taking any medication as follows: anticholinergic agents/medications with anticholinergic effect (list of prohibited drugs attached in Appendix G; antidepressants are permissible if the patient's symptoms are stable, and the doses are NOT changed during the course of the study), warfarin, prokinetics (i.e., Domperidone, Metoclopramide), narcotic analgesics, or any agent that might interfere with the evaluation of TU-100 in the opinion of the investigator.
- Have a history of allergic reaction or hypersensitivity to ginseng, ginger, and Sichuan pepper.
- Have severe dysphagia to food or pills.
- Have participated in any other clinical study within 30 days before enrolling in this study.
- Be unsuitable for participation in this trial for any reason, according to the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colon and Rectal Surgery Associates
Minneapolis, Minnesota, 55407
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation
The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.
- Conditions
- Functional Constipation
- Being tested
- DAIKENCHUTO (TU-100), Placebo
- Keywords
- Gastric Emptying
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 be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days.
PlaceboDrug
Subjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo TID Receives: Drug: Placebo |
| DAIKENCHUTO (TU-100) 15 g/day | Experimental | TU-100 5g TID Receives: Drug: DAIKENCHUTO (TU-100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 28 in CSI total score
Measured: Up to 10 weeks
Secondary outcomes (5)
Change from baseline in GI transit time measured by SmartPill capsule.
Measured: Up to 10 weeks
Change from baseline to Day 28 in CRQOL total score.
Measured: Up to 10 weeks
Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary.
Measured: Up to 10 weeks
Change from baseline to Day 28 in CSI subscale scores.
Measured: Up to 10 weeks
Change from baseline to Day 28 in CRQOL subscale scores.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsumura USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- Anders F Mellgren, MD, PhD, Principal investigator, Colon and Rectal Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348152
- Sponsor's protocol ID
- TU100CPT3
- Status last verified
- Sep 2013
- First submitted
- 3 May 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation
- ClinicalTrials.gov ID
- NCT01348152
- Acronym / sponsor ID
- TU100CPT3
- Conditions
- Functional Constipation
- Keywords
- Gastric Emptying
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 May 2011 (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.
The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo TID |
| DAIKENCHUTO (TU-100) 15 g/day | Experimental | Drug: DAIKENCHUTO (TU-100)TU-100 5g TID |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have severity of constipation in CSI score of 25 to 74 points.
- Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
- Be male or female aged between 18 and 80 years old, inclusive.
- Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
- If a female is of childbearing potential and sexually active:
Key exclusion criteria (14 listed)
- Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
- Presence of implanted or portable electro-mechanical medical devices.
- History of gastric bezoar or swallowing disorders.
- History of gastrointestinal surgery within 3 months of screening.
- History of bowel resection.
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 (TU-100)Subjects will be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days. | Drug | DAIKENCHUTO (TU-100) 15 g/day |
| PlaceboSubjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days. | Drug | Placebo |
Primary outcome
Change from baseline to Day 28 in CSI total score
Time frame: Up to 10 weeks
5 secondary outcomes
Change from baseline in GI transit time measured by SmartPill capsule.
Time frame: Up to 10 weeks
Change from baseline to Day 28 in CRQOL total score.
Time frame: Up to 10 weeks
Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary.
Time frame: Up to 10 weeks
Change from baseline to Day 28 in CSI subscale scores.
Time frame: Up to 10 weeks
Change from baseline to Day 28 in CRQOL subscale scores.
Time frame: Up to 10 weeks
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 17 Sep 2013.
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
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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.
Anders F Mellgren, MD, PhD principal investigator
Colon and Rectal Surgery Associates
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 (TU-100) in people with Functional Constipation, 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 10 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: finished, as of the sponsor's last update on 17 Sep 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 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?
Change from baseline to Day 28 in CSI total score (time frame: Up to 10 weeks). 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 17 Sep 2013.