NCT01113619

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

6 months

First QC Date

April 23, 2010

Last Update Submit

December 6, 2011

Conditions

Lactose Intolerance

Keywords

lactose maldigestiondairy intoleranceintolerance to milkintolerance to dairymilk intoleranceGI disorderlactose metabolismGI symptoms after dairy ingestion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Subjects with Adverse Events as Measure of Safety and Tolerability

    36 days

Study Arms (2)

RP-G28

EXPERIMENTAL

Study Drug RP-G28

Drug: RP-G28 or placebo

Placebo

PLACEBO COMPARATOR

Study Drug Placebo

Drug: RP-G28 or placebo

Interventions

RP-G28 or placeboDRUG

Qualified subjects randomized to daily dosing with RP-G28 or placebo

PlaceboRP-G28

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects. Female subjects must be non-pregnant and non-lactating.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Covance, Inc. - Honolulu

Honolulu, Hawaii, 96813, United States

Location

Covance, Inc. - Dallas

Dallas, Texas, 75247, United States

Location

Related Publications (1)

  • 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.

    PMID: 24330605DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Interventions

RP-G28

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 30, 2010

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

US(2)