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

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

Brief Summary:
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.

Condition or disease Intervention/treatment Phase
Lactose Intolerance Drug: RP-G28 or placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RP-G28
Study Drug RP-G28
Drug: RP-G28 or placebo
Qualified subjects randomized to daily dosing with RP-G28 or placebo

Drug: RP-G28 or placebo
Daily dosing

Placebo Comparator: Placebo
Study Drug Placebo
Drug: RP-G28 or placebo
Qualified subjects randomized to daily dosing with RP-G28 or placebo

Drug: RP-G28 or placebo
Daily dosing

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113619

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United States, Hawaii
Covance, Inc. - Honolulu
Honolulu, Hawaii, United States, 96813
United States, Texas
Covance, Inc. - Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Ritter Pharmaceuticals, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ritter Pharmaceuticals, Inc. Identifier: NCT01113619    
Other Study ID Numbers: G28-001
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Keywords provided by Ritter Pharmaceuticals, Inc.:
lactose maldigestion
dairy intolerance
intolerance to milk
intolerance to dairy
milk intolerance
GI disorder
lactose metabolism
GI symptoms after dairy ingestion
Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases