Evaluation of Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03563859
• Other study ID #: G28-006
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2018
• Est. completion date: May 2019

Study information

• Verified date: June 2018
• Source: Ritter Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ritter Pharmaceuticals, Inc. is developing RP G28 as a treatment for Lactose Intolerance. Lactose intolerance is a syndrome of gastrointestinal symptoms resulting from a deficiency in intestinal lactase relative to the amount of lactose consumed. Efficacy of RP-G28 will be evaluated by the reduction of lactose intolerance-associated symptoms. The primary objective of this study is to assess the efficacy of RP G28 compared to placebo on symptom reduction related to lactose intolerance.

Description:

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 6 study periods divided into Part A and Part B.

• Part A includes a 14-day Screening Period to determine eligibility including baseline daily lactose consumption, daily symptom assessment, and a 1-week placebo run-in, a 30-day double-blind Treatment Period (no dairy consumption), a 30-day Real World Experience Period to assess study drug response (dairy allowed ad libitum), and a 2-month added Durability Period (dairy allowed ad libitum).

• Part B is contiguous with (ie, begins immediately after) Part A and includes a blinded re-randomization to a 30-day Retreatment Period (no dairy consumption) followed by a 7-day Real World Experience Period (dairy allowed ad libitum).

Throughout the study, patients will undergo blinded Solution Z Assessment (SZA)/lactose challenges and patient reported outcome (PRO) assessments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 525
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient is a male or female

2. 18-75 years of age, inclusive, at screening

3. Current or recent history of intolerance to milk and other dairy products of at least 1-month duration

4. Patient agrees to refrain from all other treatments and products used for lactose intolerance

5. Patient agrees to follow diet modifications required during periods of the study including abstaining Fromm a ll dairy ducts some periods and racing dairy at others.

6. Patients be able and willing to return for all clinic visits and comply with all study-related procedures as required by the study protocol.

7. Patient is verbally fluent in English or Spanish, understands study procedures, and agrees to participate in the study by providing written informed consent.

8. Patient meets the defined minimum lactose intolerance symptom composite score at Visit

9. Patient has positive HBT results for lactase deficiency at Visit 2, defined as 2 or more time points with an increase = 20 parts per million hydrogen over the baseline value during the five hour test.

10. Patient has = 78% compliance (taken at least 11 of 14 doses) during the placebo run-in period.

Exclusion Criteria:

1. Patient's response to the Visit 1 Assessment of Symptom Satisfaction is 4=very satisfied or 5=completely satisfied

2. 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.

3. Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation)

4. 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 fro Crohn's disease or ulcerative colitis.

5. Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to Screening (Visit 1). Bowel patterns must have returned to normal by Visit 1.

6. Patient has a past or present condition of any of the following: Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, irritable bowel syndrome, inflammatory bowel disease (Ulcerative colitis and Crohn's disease), small intestine bacterial overgrowth syndrome, active gastric or duodenal ulcers, or history of complicated peptic ulcer disease resulted in perforation and/or obstruction or were considered refractory, giant (greater than 2 centimeters) or considered a pyloric channel, patients having had cholecystectomy in the past with no further sequelae may be included in the study at the discretion of the investigator.

7. Patient has poorly controlled Type 1 or Type 2 Diabetes Mellitus as evidenced by a screening fasting glucose >180 mg/dL; one repeat test is allowed.

8. Patient is treated with acarbose (eg, Precose), cholestyramine, colesevalam, or desiccated thyroid preparations and unable to discontinue these medications, or be on a stable dose of a replacement therapy for = 4 weeks by screening (Visit 1) and stable for duration of the study.

9. Patient typically consumes food or items that contain sorbitol estimated at = 5 g/day.

10. . Patient has a history of hypothyroidism and is not on a stable hormone therapy for at least 3 months prior to the screening visit (Visit 1) or does not have a thyroid-stimulating hormone value within normal range (tested at Visit 1).

11. Patient has Congestive Heart Failure (New York Heart Association Class III, IV only).

12. Patient has uncontrolled blood pressure defined as sitting systolic blood pressure =160 mmHg or diastolic blood pressure =95 mmHg at Visit 1.

13. Patient has any of the following lab results at Visit 1:

• Aspartate aminotransferase or alanine aminotransferase >5 x upper limit of normal

• Conjugated bilirubin >1.2 x upper limit of normal

• Severe renal insufficiency as documented by an estimated Glomerular Filtration Rate <30mL/min/1.73m squared (as calculated by Modification of Diet in Renal Disease equation, or on dialysis:

• alkaline phosphatase >1.5 x upper limit of normal

• Hemoglobin <10 g/dL for females or <11 g/dL for males

14. Patient tests positive for Hepatitis B or Hepatitis C at Visit 1.

15. Patient is HIV positive by medical history.

16. Patient has a history of alcohol abuse or routinely consumes more than 3 (women), 4 (men) alcoholic drinks per day or 7 (women), 14 (men) alcoholic drinks per week or engages in binge drinking.

17. Patient has a history of drug abuse within 12 months prior to Screening, or is currently a chronic user of opioids, or naloxegol, or loperamide.

18. Patient chronically uses medications associated with gastrointestinal side effects such as nonsteroidal anti-inflammatory drugs, high dose aspirin; or patient has initiated a chronic prescription medication within 2 weeks of screening that might result in gastrointestinal side effects (example, metformin).

19. Patient requires treatment with digoxin.

20. Patient has a current presence or medical history of a malignancy within the past 5 years, with the exception of a basal cell or squamous cell carcinoma which has already been successfully removed from a sun exposed area of the body.

21. Patient has used an investigational drug or has participated in any investigational study within 30 days prior to screening; or patient has used an investigational biologic within 6 months prior to screening.

22. Patient has previously participated in another study with RP-G28.

23. Patient has an allergy or hypersensitivity to galactic-oligosaccharides or a component of the study drug or placebo;

24. Patient has any other significant condition, disease, or disorder that in the Investigator's opinion would jeopardize the safety of the patient, affect the patient's participation in this study, or confound results or interpretation of results of the study.

25. Patient completes Daily Symptom Assessments and/or Daily Lactose Consumption in less than 78% of days (ie, patient completed less than 11 of the 14 days) at Visit 2.

26. Patient's response to the Visit 2 Patient Global Impression of Change is "1=greatly improved" or "2=moderately improved".

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• RP-G28
powder for reconstitution for oral administration
• Placebos
powder for reconstitution for oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ritter Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the efficacy of RP-G28 compared to placebo on the reduction from baseline of the lactose intolerance symptoms	Change in lactose intolerance symptoms will be assessed by questionnaire using a Likert scale (Lactose Symptom Questionnaire, Daily Lactose Consumption, Patient Global Impression of Change, Patient Global Impression of Severity, Assessment of Adequate Relief, Patient Assessment of living with lactose intolerance, Assessment of Symptom Satisfaction, and Gut Disruption).	at day 61