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

Primary Purpose

Lactose Intolerance

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RP-G28 or placebo
RP-G28 or placebo
Sponsored by
Ritter Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lactose Intolerance focused on measuring lactose maldigestion, dairy intolerance, intolerance to milk, intolerance to dairy, milk intolerance, GI disorder, lactose metabolism, GI symptoms after dairy ingestion

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Covance, Inc. - Honolulu
  • Covance, Inc. - Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RP-G28

Placebo

Arm Description

Study Drug RP-G28

Study Drug Placebo

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2010
Last Updated
December 6, 2011
Sponsor
Ritter Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01113619
Brief Title
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ritter Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
Keywords
lactose maldigestion, dairy intolerance, intolerance to milk, intolerance to dairy, milk intolerance, GI disorder, lactose metabolism, GI symptoms after dairy ingestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RP-G28
Arm Type
Experimental
Arm Description
Study Drug RP-G28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study Drug Placebo
Intervention Type
Drug
Intervention Name(s)
RP-G28 or placebo
Intervention Description
Qualified subjects randomized to daily dosing with RP-G28 or placebo
Intervention Type
Drug
Intervention Name(s)
RP-G28 or placebo
Intervention Description
Daily dosing
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of Subjects with Adverse Events as Measure of Safety and Tolerability
Description
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame
36 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Covance, Inc. - Honolulu
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Covance, Inc. - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24330605
Citation
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.
Results Reference
derived

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

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