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Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

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ClinicalTrials.gov Identifier: NCT01113619
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 23, 2010
First Posted Date  ICMJE April 30, 2010
Last Update Posted Date December 8, 2011
Study Start Date  ICMJE April 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge [ Time Frame: Baseline, 36 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
Change from Baseline in breath hydrogen production on Hydrogen Breath Test [ Time Frame: Baseline, 30 days ]
Change History Complete list of historical versions of study NCT01113619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 36 days ]
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 30 days ]
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
Official Title  ICMJE Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effectiveness, Safety and Tolerability of RP-G28 in Subjects With Symptoms Associated With Lactose Intolerance
Brief Summary This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.
Detailed Description

Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming too much lactose or when lactose is added to a previously low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain/cramps, bloating, flatulence [gas] and diarrhea. As such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet.

Based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance. This study will evaluate a treatment that provides a simplified dosing regimen as well as the potential for extended relief from symptoms following a limited therapy regimen.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lactose Intolerance
Intervention  ICMJE
  • Drug: RP-G28 or placebo
    Qualified subjects randomized to daily dosing with RP-G28 or placebo
  • Drug: RP-G28 or placebo
    Daily dosing
Study Arms  ICMJE
  • Experimental: RP-G28
    Study Drug RP-G28
    Interventions:
    • Drug: RP-G28 or placebo
    • Drug: RP-G28 or placebo
  • Placebo Comparator: Placebo
    Study Drug Placebo
    Interventions:
    • Drug: RP-G28 or placebo
    • Drug: RP-G28 or placebo
Publications * Savaiano DA, Ritter AJ, Klaenhammer TR, James GM, Longcore AT, Chandler JR, Walker WA, Foyt HL. Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial. Nutr J. 2013 Dec 13;12:160. doi: 10.1186/1475-2891-12-160.

*   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: December 6, 2011)
61
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2010)
24
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects. Female subjects must be non-pregnant and non-lactating.
  • 18 to 64 years of age inclusive at Screening
  • Current or recent history of intolerance to milk and other dairy products
  • Acceptable Baseline Lactose Intolerance Symptom Scores
  • Acceptable Result on Baseline Hydrogen Breath Test
  • Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study

Exclusion Criteria:

  • Disorders known to be associated with abnormal GI motility
  • History of surgery that alters the normal function of the gastrointestinal tract
  • Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS)
  • Active gastric or duodenal ulcers or history of severe ulcers
  • Diabetes mellitus (type 1 or type 2)
  • Congestive Heart Failure
  • History of Human Immunodeficiency Virus (HIV), Hepatitis B or C
  • Use of concurrent therapy(ies) for symptoms of lactose intolerance
  • Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1
  • History of ethanol abuse in the past 12 months
  • History of drug abuse within 12 months
  • History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area)
  • Use of any investigational drug or participation in any investigational study within 30 days prior to Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (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 NCT01113619
Other Study ID Numbers  ICMJE G28-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ritter Pharmaceuticals, Inc.
Study Sponsor  ICMJE Ritter Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ritter Pharmaceuticals, Inc.
Verification Date December 2011

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