- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139216
Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic, Rochester Methodist CRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo TID
|
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.
|
Experimental: Daikenchuto (TU-100) 7.5g/day
Daikenchuto (TU-100) 2.5g TID (7.5g/day)
|
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.
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.
|
Experimental: Daikenchuto (TU-100) 15g/day
Daikenchuto (TU-100) 5g TID (15g/day)
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Colonic geometric center at 24 hours measured by scintigraphy
Time Frame: Up to 48 hours
|
Up to 48 hours
|
T1/2 of ascending colon emptying as measured by scintigraphy
Time Frame: Up to 48 hours
|
Up to 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stool frequency
Time Frame: 6 weeks
|
6 weeks
|
Stool consistency
Time Frame: 6 weeks
|
6 weeks
|
Colonic geometric center at 4 hours and 48 hours
Time Frame: Up to 48 hours
|
Up to 48 hours
|
Colonic filling at 6 hours
Time Frame: Up to 48 hours
|
Up to 48 hours
|
t1/2 of gastric emptying of solid
Time Frame: Up to 48 hours
|
Up to 48 hours
|
Rectal Compliance Pr1/2
Time Frame: Up to 3 hours
|
Up to 3 hours
|
Rectal sensation thresholds (gas, urgency to defecate, and pain)
Time Frame: Up to 3 hours
|
Up to 3 hours
|
Anal sphincter pressure at rest
Time Frame: Up to 3 hours
|
Up to 3 hours
|
Anal sphincter pressure during squeeze
Time Frame: Up to 3 hours
|
Up to 3 hours
|
Recto-anal pressure difference during straining to simulate defecation
Time Frame: Up to 3 hours
|
Up to 3 hours
|
PAC-QOL (Patient Assessment of Constipation Quality of Life) score
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU100CPT2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Constipation
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
Huazhong University of Science and TechnologyWuhan Union Hospital, China; Guangzhou University of Traditional Chinese Medicine and other collaboratorsUnknownFunctional Constipation | Functional DiarrheaChina
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Chulalongkorn UniversityNot yet recruitingFunctional ConstipationThailand
-
Min-Tze LIONGDeyang People's HospitalRecruiting
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional ConstipationUnited States, Bulgaria, United Kingdom, Croatia, Germany, Hungary
-
University of AlexandriaRecruitingFunctional ConstipationEgypt
-
Gelesis, Inc.Not yet recruitingConstipation - Functional
-
Wageningen University and ResearchAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); FrieslandCampina... and other collaboratorsRecruitingFunctional ConstipationNetherlands
-
Société des Produits Nestlé (SPN)CompletedConstipation - FunctionalIreland
Clinical Trials on Daikenchuto (TU-100)
-
Tsumura USAICON Clinical ResearchCompletedIrritable Bowel Syndrome in FemalesUnited States
-
Tsumura USARecruitingEnhanced Recovery After SurgeryUnited States
-
Tsumura USACato ResearchCompletedPostoperative IleusUnited States
-
Tsumura USACato ResearchCompletedDigestive System Diseases | Gastrointestinal Diseases | Irritable Bowel Syndrome | Intestinal Diseases | Abdominal PainUnited States
-
Tsumura USACato ResearchCompleted
-
Tsumura USACompletedPostoperative IleusUnited States
-
Tsumura USASyneos HealthTerminatedCrohn's DiseaseUnited States
-
Tsumura USACato ResearchCompletedPostoperative IleusUnited States
-
West China Second University HospitalActive, not recruitingUterine Sarcoma | Uterine Fibroid | Uterine LeiomyosarcomaChina
-
The University of Texas Health Science Center,...CompletedObesity | Physical Activity | Stress | DietUnited States