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

Lactose Intolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113619
• Other study ID #: G28-001
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2010
• Last updated: December 6, 2011
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Ritter Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• RP-G28 or placebo
Qualified subjects randomized to daily dosing with RP-G28 or placebo
• RP-G28 or placebo
Daily dosing

Locations

Country	Name	City	State
United States	Covance, Inc. - Dallas	Dallas	Texas
United States	Covance, Inc. - Honolulu	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Ritter Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge		Baseline, 36 days	No
Secondary	Number of Subjects with Adverse Events as Measure of Safety and Tolerability	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	36 days	Yes