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NCT03597516 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
A Phase 3 study, sponsored by Ritter Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 557
- Enrollment target
NCT03597516: Completed Phase 3 study, sponsored by Ritter Pharmaceuticals.
NCT03597516 is a Phase 3 study that has completed, run by Ritter Pharmaceuticals. The registered enrollment target is 557 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597516, a Phase 3 study, has completed, sponsored by Ritter Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 557 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebos
- DRUG RP-G28
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2019-07-02 |
| Phase | Phase 3 |
What the finished NCT03597516 record still lists
NCT03597516 is an interventional study that assigns participants to a tested intervention. The registered 557 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03597516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03597516 about?
NCT03597516 is a clinical study titled "Evaluation of 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.
What is the current status of trial NCT03597516?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2018-06-26. Estimated completion is 2019-07-02.
What interventions are being tested in trial NCT03597516?
The interventions under investigation include: Placebos (DRUG), RP-G28 (DRUG).
Who is sponsoring clinical trial NCT03597516?
This trial is sponsored by Ritter Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03597516's enrollment target sits among peer trials
557 674th of 2000 higher than 1,326 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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