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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01113619
First received: April 23, 2010
Last updated: December 6, 2011
Last verified: December 2011

April 23, 2010
December 6, 2011
April 2011
October 2011   (final data collection date for primary outcome measure)
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 ]
Change from Baseline in breath hydrogen production on Hydrogen Breath Test [ Time Frame: Baseline, 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01113619 on ClinicalTrials.gov Archive Site
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
Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Not Provided
Not Provided
 
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lactose Intolerance
  • Drug: RP-G28 or placebo
    Qualified subjects randomized to daily dosing with RP-G28 or placebo
  • Drug: RP-G28 or placebo
    Daily dosing
  • 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
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.
 
Completed
61
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01113619
G28-001
No
Ritter Pharmaceuticals, Inc.
Ritter Pharmaceuticals, Inc.
Not Provided
Not Provided
Ritter Pharmaceuticals, Inc.
December 2011

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