Functional Constipation Clinical Trial
Official title:
Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients With Functional Constipation
Verified date | September 2020 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
INCLUSION CRITERIA 1. Females aged 18 to 65 years old inclusive 2. A diagnosis of functional constipation as defined by two or more of the following: 1. fewer than three spontaneous complete bowel movements per week 2. hard or lumpy stools more than 25 % of the time 3. straining during a bowel movement more than 25 % of the time 3. A normal rectal exam result on file within the past 2 years or performed at screen 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. 4. Females of child-bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an IUD. Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study. 5. Able to provide written informed consent prior to any study procedures being performed EXCLUSION CRITERIA 1. Female patients who are pregnant or breast feeding 2. Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders other than constipation. The long version BDQ will be used to confirm patients have constipation. 3. Unable to withdraw all medications 48 hours prior to Visit 1; any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids. prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and SNRIs; analgesic drugs including opiates, NSAIDs, and COX-2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians. 4. Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory test result 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 PI. 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 further evaluation. 5. Patients who are considered by the PI to be alcoholics not in remission or known substance abusers. 6. Patients who have participated in another clinical study in the past 30 days. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Michael Camilleri, MD | National Center for Research Resources (NCRR) |
United States,
Wong BS, Camilleri M, McKinzie S, Burton D, Graffner H, Zinsmeister AR. Effects of A3309, an ileal bile acid transporter inhibitor, on colonic transit and symptoms in females with functional constipation. Am J Gastroenterol. 2011 Dec;106(12):2154-64. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Colonic Transit at 24 Hours | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic transit was measured by quantification of radioactive counts via abdominal scintiscans. Overall colonic transit was computed as the colonic geometric center (GC), which is the weighted average of counts in the different colonic regions (ascending, transverse, descending, rectosigmoid and stool), respectively numbered 1 to 5. At any time point, the GC equals the proportion of counts in each colonic region multiplied by its weighting factor: (%ACx1+%TCx2+%DCx3+%RSx4+%stoolx5)/100. As such, a higher GC reflects faster colonic transit. A GC of 1 implies all the isotope is in the ascending colon and a GC of 5 implies all the isotope is in the stool. | 24 hours post-radiolabeled meal | |
Secondary | Colonic Filling | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic filling was measured by scintigraphy as the percentage of the radiolabeled meal that reached the colon at 6 hours. | 6 hours post-radiolabeled meal | |
Secondary | Gastric Emptying , T1/2 | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying (GE t 1/2) was measured by scintigraphy and defined as the time required for 50% of the radiolabeled tracer to empty from the stomach. | post-treatment, approximately 12-14 days | |
Secondary | Ascending Colon Emptying t 1/2 | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Ascending colon emptying t 1/2 was measured by scintigraphy and defined as the time required for 50% of the radiolabeled tracer to empty from the ascending colon. | post-treatment, approximately 12-14 days | |
Secondary | Colonic Transit at 8 Hours | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic transit was measured by quantification of radioactive counts via abdominal scintiscans. Overall colonic transit was computed as the colonic geometric center (GC), which is the weighted average of counts in the different colonic regions (ascending, transverse, descending, rectosigmoid and stool), respectively numbered 1 to 5. At any time point, the GC equals the proportion of counts in each colonic region multiplied by its weighting factor: (%ACx1+%TCx2+%DCx3+%RSx4+%stoolx5)/100. As such, a higher GC reflects faster colonic transit. A GC of 1 implies all the isotope is in the ascending colon and a GC of 5 implies all the isotope is in the stool. | 8 hours post-radiolabeled meal | |
Secondary | Colonic Transit at 48 Hours | Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic transit was measured by quantification of radioactive counts via abdominal scintiscans. Overall colonic transit was computed as the colonic geometric center (GC), which is the weighted average of counts in the different colonic regions (ascending, transverse, descending, rectosigmoid and stool), respectively numbered 1 to 5. At any time point, the GC equals the proportion of counts in each colonic region multiplied by its weighting factor: (%ACx1+%TCx2+%DCx3+%RSx4+%stoolx5)/100. As such, a higher GC reflects faster colonic transit. A GC of 1 implies all the isotope is in the ascending colon and a GC of 5 implies all the isotope is in the stool. | 48 hours post-radiolabeled meal | |
Secondary | Stool Frequency | Subjects maintained a validated daily bowel diary and recorded the number of bowel movements each day during treatment. | 14 days | |
Secondary | Stool Consistency | Subjects maintained a validated daily bowel diary during treatment and recorded stool consistency according to the Bristol Stool Form Scale, where: 1= separate hard lumps; 2= lumpy sausage-shape; 3= cracked sausage; 4= smooth and soft sausage; 5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces. | 14 days | |
Secondary | Treatment Effectiveness of A3309 | Subject perception of treatment efficacy was measured using a 5 point numerical scale where 1=not at all effective to 5=extremely effective. | Day 14 |
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