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Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

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ClinicalTrials.gov Identifier: NCT03597516
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo [ Time Frame: Day 61 ]
Change from baseline of the LI symptom composite score compared to placebo. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo [ Time Frame: Day 61 ]
Change from baseline of the LI symptom composite score compared to placebo
Change History Complete list of historical versions of study NCT03597516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Proportion of patients with a meaningful reduction in LI composite score. [ Time Frame: Day 61 ]
Proportion of patients with a meaningful reduction in LI composite score. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Change from baseline of the LI symptom composite score compared to placebo [ Time Frame: Day 120 ]
Change from baseline of the LI symptom composite score compared to placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
Brief Summary This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 4 study periods.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lactose Intolerance
Intervention  ICMJE
  • Drug: RP-G28
    powder for reconstitution for oral administration
  • Drug: Placebos
    powder for reconstitution for oral administration
Study Arms  ICMJE
  • Experimental: RP-G28
    galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day
    Intervention: Drug: RP-G28
  • Placebo Comparator: Placebos
    maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
557
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2018)
525
Actual Study Completion Date  ICMJE July 2, 2019
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is 18-75 years of age, inclusive, at screening;
  • Intolerance to milk and other dairy products;
  • Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
  • Patient meets the defined minimum lactose intolerance symptom composite score; and
  • Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.

Exclusion Criteria:

  • Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
  • Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
  • Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
  • Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597516
Other Study ID Numbers  ICMJE G28-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ritter Pharmaceuticals, Inc.
Study Sponsor  ICMJE Ritter Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sharron Gargosky, PhD Ritter Pharmceuticals, Inc.
PRS Account Ritter Pharmaceuticals, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP