Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
- Conditions
- Lactose Intolerance
- Interventions
- Drug: RP-G28 or placebo
- Registration Number
- NCT01113619
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RP-G28 RP-G28 or placebo Study Drug RP-G28 Placebo RP-G28 or placebo Study Drug Placebo
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Number of Subjects with Adverse Events as Measure of Safety and Tolerability 36 days Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Trial Locations
- Locations (2)
Covance, Inc. - Honolulu
🇺🇸Honolulu, Hawaii, United States
Covance, Inc. - Dallas
🇺🇸Dallas, Texas, United States