Lactose IntolerancePhase 2NCT01113619
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
A Phase 2 study of Lactose Intolerance, run by Ritter Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lactose Intolerance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance, Inc. - Dallas
Dallas, Texas, 75247
Covance, Inc. - Honolulu
Honolulu, Hawaii, 96813
About this study
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
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.
Read the 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.
- Conditions
- Lactose Intolerance
- Being tested
- RP-G28 or placebo
- Keywords
- lactose maldigestion, dairy intolerance, intolerance to milk, intolerance to dairy, milk intolerance, GI disorder, lactose metabolism, GI symptoms after dairy ingestion
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP-G28 or placeboDrug
Qualified subjects randomized to daily dosing with RP-G28 or placebo
RP-G28 or placeboDrug
Daily dosing
| Study group | Role | What they receive |
|---|---|---|
| RP-G28 | Experimental | Study Drug RP-G28 Receives: Drug: RP-G28 or placebo |
| Placebo | Placebo comparator | Study Drug Placebo Receives: Drug: RP-G28 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge
Measured: Baseline, 36 days
Secondary outcomes (1)
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
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ritter Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113619
- Sponsor's protocol ID
- G28-001
- Status last verified
- Dec 2011
- First submitted
- 23 Apr 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24330605
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01113619
- Acronym / sponsor ID
- G28-001
- Conditions
- Lactose Intolerance
- Keywords
- lactose maldigestion, dairy intolerance, intolerance to milk, intolerance to dairy, milk intolerance, GI disorder, lactose metabolism, GI symptoms after dairy ingestion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ritter Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP-G28 | Experimental | Drug: RP-G28 or placeboStudy Drug RP-G28 |
| Placebo | Placebo comparator | Drug: RP-G28 or placeboStudy Drug Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP-G28 or placeboQualified subjects randomized to daily dosing with RP-G28 or placebo | Drug | Placebo, RP-G28 |
| RP-G28 or placeboDaily dosing | Drug | Placebo, RP-G28 |
Primary outcome
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
1 secondary outcome
Number of Subjects with Adverse Events as Measure of Safety and Tolerability
Time frame: 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Derived from this study: PubMed 24330605Savaiano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Lactose Intolerance, run by Ritter Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.