Lactose IntolerancePhase 3NCT03597516
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
A Phase 3 study testing RP-G28 in people with Lactose Intolerance, run by Ritter Pharmaceuticals, Inc. at 35 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- RP-G28
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 557 participants
- Where
- 35 sitesUnited States
- Study dates
- 26 Jun 2018to 2 Jul 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18-75 years of age, inclusive, at screening;
- Intolerance to milk and other dairy products;
- Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
- Patient meets the defined minimum lactose intolerance symptom composite score; and
- Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.
Who cannot join
- Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
- Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
- Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
- Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Research Site
Albuquerque, New Mexico, 87102
Research Site
Bellevue, Washington, 98004
Research Site
Berlin, New Jersey, 08009
Research Facility
Birmingham, Alabama, 35205
Research Site
Brooklyn, New York, 11230
Research Site
Charleston, South Carolina, 29406
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45246
Research Site
Colorado Springs, Colorado, 80906
Research Site
Dayton, Ohio, 45439
Research Site
Fairfax, Virginia, 22031
Research Site
Gainesville, Florida, 32653
Research Site
Great Neck, New York, 11023
Research Site
Hartsdale, New York, 10530
Research Site
Honolulu, Hawaii, 96815
Research Site
Houston, Texas, 77099
Research Site
Huntington Park, California, 90255
Research Site
Knoxville, Tennessee, 37909
Research Site
Lampasas, Texas, 76550
Research Site
Lincoln, California, 95648
Research Site
Los Angeles, California, 90057
Research Site
Marrero, Louisiana, 70072
Research Facility
Miami, Florida, 33135
Research Site
Omaha, Nebraska, 68114
Research Site
Orlando, Florida, 32806
Research Site
Oxon Hill, Maryland, 20745
Research Site
Panorama City, California, 91402
Reseaarch Site
Pompano Beach, Florida, 33060
Research Site
Raleigh, North Carolina, 27612
Research Site
San Antonio, Texas, 78209
Research Site
San Diego, California, 92114
Research Site
San Diego, California, 92123
Research Site
Walnut Creek, California, 94598
Research Site
Waxahachie, Texas, 75165
Research Site
Wyoming, Michigan, 49519
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.
- Conditions
- Lactose Intolerance
- Being tested
- RP-G28, Placebos
- Keywords
- Lactose Intolerance
- 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-G28Drug
powder for reconstitution for oral administration
PlacebosDrug
powder for reconstitution for oral administration
| Study group | Role | What they receive |
|---|---|---|
| RP-G28 | Experimental | galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day Receives: Drug: RP-G28 |
| Placebos | Placebo comparator | maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo
Change from baseline of the LI symptom composite score compared to placebo. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
Measured: Day 61
Secondary outcomes (1)
Proportion of patients with a meaningful reduction in LI composite score.
Proportion of patients with a meaningful reduction in LI composite score. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
Measured: Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start26 Jun 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 4 study periods.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ritter Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharron Gargosky, PhD, Study director, Ritter Pharmceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597516
- Sponsor's protocol ID
- G28-006
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
- ClinicalTrials.gov ID
- NCT03597516
- Acronym / sponsor ID
- G28-006
- Conditions
- Lactose Intolerance
- Keywords
- Lactose Intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Ritter Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 24 Jul 2018 (actual)
- 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 multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 4 study periods.
| Arm | Type | Receives |
|---|---|---|
| RP-G28 | Experimental | Drug: RP-G28galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day |
| Placebos | Placebo comparator | Drug: Placebosmaltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 18-75 years of age, inclusive, at screening;
- Intolerance to milk and other dairy products;
- Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
- Patient meets the defined minimum lactose intolerance symptom composite score; and
- Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.
Key exclusion criteria (4 listed)
- Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
- Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
- Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
- Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
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-G28powder for reconstitution for oral administration | Drug | RP-G28 |
| Placebospowder for reconstitution for oral administration | Drug | Placebos |
Primary outcome
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo
Time frame: Day 61
Change from baseline of the LI symptom composite score compared to placebo. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
1 secondary outcome
Proportion of patients with a meaningful reduction in LI composite score.
Time frame: Day 61
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 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sharron Gargosky, PhD study director
Ritter Pharmceuticals, Inc.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RP-G28 in people with Lactose Intolerance, run by Ritter Pharmaceuticals, Inc. at 35 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 5 inclusion and 4 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo (time frame: Day 61). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.