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Trial record 2 of 8201 for:    QOL medical

A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency (GSID-E)

This study has been withdrawn prior to enrollment.
(Clinical Trial Material)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02784067
First Posted: May 26, 2016
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
QOL Medical, LLC
  Purpose
S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase deficiency.

Condition Intervention Phase
Genetic Sucrase-Isomaltase Deficiency Drug: Sucraid Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency

Resource links provided by NLM:


Further study details as provided by QOL Medical, LLC:

Primary Outcome Measures:
  • Response to Sucraid and placebo in a parallel group study based on improvement in daily stool consistency, as assessed by the BSFS using SHMBT [ Time Frame: Up to 2 years ]
    Response to Sucraid and placebo based on improvement in daily stool consistency, as assessed by the Bristol Stool Form Scale (BSFS) over a 1-week treatment period in subjects with chronic diarrhea and sucrase deficiency using a sucrose hydrogen methane breath test (SHMBT).


Secondary Outcome Measures:
  • Effects of Sucraid and placebo on daily assessments of Bristol Stool Form Scale [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily stool frequency [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily abdominal pain [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily bloating severity [ Time Frame: Up to 2 years ]
  • The relationship between the severity of sucrase deficiency, quantified by a SHMBT [ Time Frame: Up to 2 years ]
  • The mean improvement in the BSFS for each treatment group. [ Time Frame: Up to 2 years ]
  • Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants [ Time Frame: Up to 2 years ]
    Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants in comparison to the frequency in public proxy databases of broad populations.

  • The number of less common sucrase-isomaltase polymorphisms in this study population. [ Time Frame: Up to 2 years ]
  • The allele frequency of the most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency in other databases [ Time Frame: Up to 2 years ]
    Assess the allele frequency of the 38 most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency of sucrase-isomaltase genetic variants in the Exome Variant Server, the ExAC server, and other public proxy and private genetic databases.


Enrollment: 0
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects randomized to the active treatment arm will take Sucraid, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature). The study treatment period is one week.
Drug: Sucraid
Study drug
Other Name: Sacrosidase
Placebo Comparator: Placebo
Subjects randomized to the placebo treatment arm will take Sucraid placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature). The study treatment period is one week.
Drug: Placebo
Sucraid placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 16 years of age or older.
  2. Subject is male or female. Women of childbearing potential must be willing to use one of the following contraception methods (for at least 10 days prior to start of study drug and for 10 to 14 days after last dose of study drug): Oral contraceptive, Injectable progestogen, Implants of levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches, Intrauterine device, Sterile male partner, Double-barrier method of contraception Women of non-child bearing potential include females regardless of age with functioning ovaries and who have a current tubal ligation (Hatcher, 2004), bilateral oophorectomy, or total hysterectomy, or post-menopausal females. Note: Post-menopausal is defined as 1 year without menses with an appropriate clinical profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy).
  3. Subject has a minimum of 3 months of self-reported diarrhea (BSFS scores ≥ 5 on at least 3 days per week and ≥1 stool per day)
  4. Subject has a value in the SHMBT of at least 20 ppm for hydrogen, or 12 ppm for methane or 15 ppm above a previous breath sample for the combination of both gases.
  5. Subject reports that he/she experienced soft stools or diarrhea within the last 24 hours when contacted by the site 24 hours after completing the SHMBT.
  6. Subject is able to read, speak, and verbally understand the English language.
  7. Subject is located in the United States.
  8. Subject has access to the Internet on a daily basis.
  9. Subject has access to an acceptable Apple iPhone/iPad/iTouch or Android smartphone/tablet. The sponsor may choose to provide a smartphone in unusual cases (please contact sponsor to request loaner device when applicable)

Exclusion Criteria:

  1. Subject has recent history of functional or chronic constipation.
  2. Subject has known history of ulcerative colitis, Crohn's disease, or Celiac disease.
  3. Subject has known hypersensitivity to papain, glycerol, or yeast.
  4. Subject has received bovine serum in the last year.
  5. Subject has previous history of Sucraid use.
  6. Subject has taken any prebiotic or probiotic within 5 days prior to Visit 2 and does not agree to refrain from taking them during the study.
  7. Subject is female and is pregnant, breastfeeding, or planning to become pregnant during the study.
  8. Subject has known uncontrolled systemic disease.
  9. Subject has prior diagnosis of Type 1 or Type 2 diabetes.
  10. Subject has history of bowel resection.
  11. Subject is undergoing chemotherapy for the treatment of cancer.
  12. Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
  13. Subject has used an investigational device or investigational drug within 30 days prior to Visit 1.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Chumpitazi BP, Robayo-Torres CC, Tsai CM, Opekun AR, Baker SS, Nichols BL, Gilger MA, Su1110 Yield of prospective disaccharidase testing in children with recurrent abdominal pain. Gastroenterology. May 2013;144(5):S-401-S402.
El-Chammas K, Williams S, Miranda A. Su1254 Lactase and sucrase deficiencies in pediatric subjects with chronic abdominal pain. Gastroenterology. May 2014;146(5):S-415-S416.
Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W, Guest F, Kowal DD, editors. Contraceptive Technology. New York: Ardent Media, 2004:226.
Kerry KR, & Townley, R. R. Genetic aspects of intestinal sucrase-isomaltase deficiency. Australian Paediatric Journal. 1965;1:223.
Reed, JF. (2006) AB/BA Crossover Trials - Binary Outcome. J Modern Applied Stat Methods 5 (2): 452-457.

Responsible Party: QOL Medical, LLC
ClinicalTrials.gov Identifier: NCT02784067     History of Changes
Other Study ID Numbers: S09A
First Submitted: May 18, 2016
First Posted: May 26, 2016
Last Update Posted: September 22, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Diarrhea
Carbohydrate Metabolism, Inborn Errors
Signs and Symptoms, Digestive
Signs and Symptoms
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases