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

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: lactose intolerance

MedlinePlus related topics: Lactose Intolerance

U.S. FDA Resources

Further study details as provided by Ritter Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

Enrollment:	61
Study Start Date:	April 2011
Study Completion Date:	December 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113619

Locations

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.

More Information

No publications provided

Responsible Party:	Ritter Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01113619 History of Changes
Other Study ID Numbers:	G28-001
Study First Received:	April 23, 2010
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration

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:

Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013