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Clinical Trials

Please contact us if you would like your clinical trial listed on our website.

www.CenterWatch.com

http://www.clinicaltrials.gov

 

Irritable Bowel Syndrome With Constipation in Children Ages 7-17 Years

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (LIN-MD-63)

Purpose: The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C), in children age 7-17.

Phase of Study: Phase 2

Study Description: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 7 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation)

Gender of enrollees: Both Male and Female

Accessibility of Study: In-Person

Start and End Dates of Study: October 2015 - April 2018

Name of Center: Multiple study centers across the US

Address: Multiple addresses across the US

Location: US and Canada

Inclusion Eligibility Criteria:

      • Patient weighs at least 18 kg (39.7 lbs)
      • Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
          1. Improvement with defecation
          2. Onset associated with a change in frequency of stool
          3. Onset associated with a change in form (appearance) of stool
      • Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following:
          1. History of retentive posturing or excessive volitional stool retention
          2. History of painful or hard bowel movements (BMs)
          3. Presence of a large fecal mass in the rectum
          4. History of large diameter stools that may obstruct the toilet

Exclusion Eligibility Criteria:

      • Patient reports having more than 1 loose, mushy stool (eDiary-recorded Stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
      • Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
      • Patient has required manual or hospital-based disimpaction any time prior to randomization
      • Patient is unable to tolerate the placebo during the Screening Period

Trial Contact Name: Forest Research Institute, Inc., an affiliate of Actavis, Inc.

Study Website: WWW.MARCO-POLOSTUDIES.COM

Phone Number: 888-609-3456

Principal Investigators: Multiple Principal Investigators

 

Functional Constipation in Children Ages 6-17 Years

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) (LIN-MD-62)

Purpose: The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years

Phase of Study: Phase 2

Study Description: A multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfil Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Gender of Enrollees: Both Male and Female

Accessibility of Study: In-Person

Start and End Dates of Study: October 2015 - June 2017

Name of Center: Multiple study centers across US

Address: Multiple addresses across US

Location: US and Canada

Inclusion Eligibility Criteria:

      • Patient weighs at least 18 kg (39.7 lbs)
      • Patient meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week
      • In addition, at least once per week, patient meets 1 or more of the following:
          1. History of retentive posturing or excessive volitional stool retention
          2. History of painful or hard bowel movements (BMs)
          3. Presence of a large fecal mass in the rectum
          4. History of large diameter stools that may obstruct the toilet
      • Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
      • Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
      • Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

Exclusion Eligibility Criteria:

      • Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the Screening Visit, the patient has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
          1. Improvement with defecation
          2. Onset associated with a change in frequency of stool
          3. Onset associated with a change in form (appearance) of stool
      • Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS]) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
      • Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
      • Patient has required manual or hospital-based disimpaction any time prior to randomization
      • Patient is unable to tolerate the placebo during the Screening Period

Trial Contact Name: Forest Research Institute, Inc., an affiliate of Actavis, Inc.

Study Website: WWW.MARCO-POLOSTUDIES.COM

Phone Number: 888-609-3456

Principal Investigator(s): Multiple Principal Investigators

 

Chronic Intestinal Pseudo-Obstruction or Neuronal Dysplasia Studies

Genetic Neuronal Dysplasia or Chronic Intestinal Pseudo-Obstruction Study

Every day we learn more about how genes (the instructions for how our bodies work) are involved in diseases. If you or one of your children have a diagnosis of intestinal neuronal dysplasia or chronic intestinal pseudo-obstruction and you are interested in helping to find a genetic cause of your disease, please contact Maryangela DeGrazia-DiTucci at the Association of Gastrointestinal Motility Disorders, Inc. (AGMD) via email: maryangela@gimotility- agmd.org or telephone: 781-275-1300. Researchers at Columbia University Medical Center look forward to working with you. You may be able to help by providing a blood sample or a cheek swab.

 

Gastroparesis Studies

Aprepitant for the Relief of Nausea in Patients with Chronic Nausea and Vomiting of Presumed Gastric Origin (APRON)

http://www.hopkinsmedicine.org/johns_hopkins_bayview/research_clinical_trials/clinical_trials/gastroenterology.html

Gastroparesis Registry 2 (GpR2): Continuation of the NIDDK Registry for the Characterization and Clinical Course of Gastroparesis Patients

http://www.hopkinsmedicine.org/johns_hopkins_bayview/research_clinical_trials/clinical_trials/gastroenterology.html

Multicenter Study to Evaluate the Efficacy and Safety of Metroclopramide Nasal Spray in Women with Diabetic Gastroparesis

https://clinicaltrials.gov/ct2/show/NCT02025725?term=evk-001&rank=1

Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

https://clinicaltrials.gov/ct2/show/NCT02025751?term=evk-001&rank=2

Theravance Biopharma, Inc. (TD-5108; velusetrag)

TD-5108 is an investigational medicine being tested in patients with idiopathic or diabetic gastroparesis. This study is currently recruiting participants. There will be approximately 40 sites across the US enrolling patients. Locations are currently found in these states: AZ, CO, KS, OR, PA, TN and VA. Other sites are currently being added. More detailed information is available at the FDA's clinical trials website:

https://www.clinicaltrials.gov/ct2/show/NCT02267525?term=5108&rank=5

 

Diarrhea predominant irritable bowel study (IBS-D

Study Information

This is a Phase II clinical trial that is being undertaken to evaluate the effects of three doses of an investigational study drug on IBS-D symptoms during 4 weeks of dosing in study volunteers who have diarrhea predominant irritable bowel syndrome (IBS-D). In addition, the three doses of investigational study drug will be compared to placebo (an inactive substance). Safety assessments will also be made during the study.

•Study Duration and Visit Information: There are 6 study visits* over approximately 10 weeks. Study volunteers will undergo a screening and run-in process, lasting approximately 4 weeks, during which IBS-D symptoms and other qualifications for this study will be assessed. Those who qualify at the end of the screening and run-in periods will receive one of the four investigational study doses in a double-blinded manner (neither the study volunteer nor the staff at the research site will know which dose has been assigned). The dosing period of the study will last 4 weeks. The final study visit will occur two weeks after the end of dosing.
        *A pre-study visit may also be scheduled.
 
•Study Drug: In patients with diarrhea predominant irritable bowel syndrome (IBS-D), an amino acid that may cause disturbed bowel function appears to be present in higher than normal levels. The investigational study drug acts within the gastrointestinal tract to inhibit the production of this amino acid. Researchers wish to find out if the investigational study drug can safely and effectively relieve the symptoms of IBS-D. In this study, the researchers will evaluate the study drug in a wider population of people suffering from IBS-D than in the previous clinical trials they have carried out in this line of research. The chance of receiving each one of the four different study doses* is 25%.
        * different doses of study drug or placebo (an inactive substance)
 
•Study Procedures: Procedures for the study include physical exams, laboratory tests, and 12-lead electrocardiograms (ECG’s). Electronic diaries will be dispensed to study participants to record information between visits.
 
•There is no charge for participation. Study medication or placebo, study procedures and study visits are provided at no cost.
 
•Compensation will be provided to qualified participants to help cover study-related time and/or travel.
 
• Principal Investigator: William Elzi, M.D. of Wheat Ridge Internal Medicine
 

Key Inclusion Criteria:

•   Males or females at least 18 and no more than 70 years old

•   Diagnosed with diarrhea predominant irritable bowel syndrome (IBS-D) for at least the past 3 months, with symptoms starting at least 6 months before the diagnosis

•   If age 50 or older, must have had a colon evaluation within the past 5 years (air contrast barium enema, virtual colonoscopy or endoscopic colonoscopy), and this evaluation must be available for review

•   Females or a males capable of producing children* must be willing to use an adequate method of contraception during the study and for 30 days after the follow-up visit

NOTE: Adequate methods of contraception for study participants and their partners include condoms with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), oral contraceptive pill or depoprogesterone injections, and abstinence.

*Otherwise, female study participants should be at least 2 years postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation) and males must have had a vasectomy.

  1.     Willing and able to discontinue any current drug treatment for IBS* with the exception of bulking agents during study participation

*Includes antidiarrheal agents such as diphenoxylate (found in Lomotil) or bismuth subsalicylate (found in Pepto Bismol).

NOTE 1: Up to 2 doses of loperamide (i.e., Imodium) per week will be allowed as rescue medication during the study.


NOTE 2: Use of bulking agents such as psyllium products, fiber tablets, etc., with a stable regimen (no significant change in the past 3 months) will be allowed, but should not be discontinued, nor new such agents started, during the study.

 

Additional Inclusion Criteria will be assessed during the screening process.


Key Exclusion Criteria:

  1. •   Pregnant or nursing females

  2. •   History of lactose or gluten intolerance

  3. •   Currently smoking more than 10 cigarettes per day

  4. •   Habitually drinking more than six (8 ounce) cups of coffee per day (or an equivalent caffeine-containing beverage)

  5. •   Currently participating in another clinical research study of any type, OR participation in another clinical research study within the past 30 days, OR participation in a clinical research study for a biologic agent within the past 90 days

Additional Exclusion Criteria will be assessed during the screening process.

For more information visit http://www.wscrinc.com/WSCR,_Inc./Clinical_Trials.html

 

UC Study

Regarding the UC study:
Study Summary: UC is characterized by mucosal ulceration, rectal bleeding, diarrhea and abdominal pain. Despite the availability of a range of medications for UC, there remains a need for therapeutic alternatives because patients may not respond to existing therapeutic choices, may not maintain a good response, or may develop treatment limiting toxicities. The purpose of his study is to evaluate the safety and efficacy of an investigational intravenous (IV) medication versus placebo (an inactive substance) for induction of clinical remission at Week 7. Secondary study objectives include comparing the study drug to placebo for induction of clinical response, and for induction of mucosal healing.  The study will also assess health-related quality of life outcome via completion of a questionnaire and assess safety.  The study also has maintenance and open label treatment periods.

Study Information:

► Study duration: There are 4 study periods. The screening period may last from 7 days to 12 weeks. The induction period lasts 78 days, and the maintenance period may last up to 108 weeks. There is an open-label extension period for qualifying subjects.

► Study drug: The study medication is an intravenously administered agent, administered every other week, that has been shown to inhibit the activity of activated T cells. T cells are thought to play a key role in the development of certain disease states, including UC.

► There is no charge for participation. Study medication or placebo, study procedures and study visits are provided at no cost.

► Compensation will be provided to qualified participants to help cover study-related time and/or travel.

►Principal Investigator: William Elzi, M.D.


Key Inclusion Criteria:

► Male or female adults at least 18 years of age with a clinical diagnosis of moderate to severely active UC confirmed by endoscopic evidence for at least 6 months

► Study participants must have an inadequate response and /or intolerance to one or more conventional therapies (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist), or have been intolerant to similar treatments, or be currently receiving one of the following treatments: oral aminosalicylates for at least 6 weeks, prednisone ≥ 20 mg/day for at least 4 weeks, immunosuppressants (azathioprine

> 2mg/kg/day or 6-mercaptopurine >2.0 mg/kg/day or documentation of a therapeutic

concentration of 6-thioguanine nucleotide) for at least 12 weeks.

► Females of child bearing potential and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and up to 8 weeks after the last dose of investigational medication.


Key Exclusion Criteria:

► Diagnosis of Crohn's Disease or Indeterminate Colitis

► Diagnosis of UC that is limited to the rectum (ulcerative proctitis only) or current evidence of fulminant colitis

► Diagnosis of toxic megacolon or bowel perforation

► Current need for colostomy or ileostomy

► Previous total or subtotal colectomy

► Subjects at risk for active tuberculosis (TB) or history of active TB within the last 3 years

► Study participants may not have a history of cancer in the last 5 years (other than non-melanoma skin cancer cured by local resection).

► Study participants may not have had a serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection.

► Study participants requiring chronic use of narcotics for any reason                 

► Females who are pregnant or lactating may not participate.

► Women must not be breast feeding.

 

For more information, visit http://www.wscrinc.com/WSCR,_Inc./Clinical_Trials.html

 

 

This page was last modified on February 6, 2017

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