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NCT03198767 · ClinicalTrials.gov registry record · Phase 2
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT03198767: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03198767 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03198767, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.
Primary Outcome
Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.
Interventions
- DRUG LIK066
- DIETARY_SUPPLEMENT Carbohydrate 50%
- DIETARY_SUPPLEMENT Carbohydrate 25%
- DIETARY_SUPPLEMENT Carbohydrate 8%
- DIETARY_SUPPLEMENT Carbohydrate 0%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-06-21 |
| Est. Completion | 2017-09-04 |
| Phase | Phase 2 |
What the finished NCT03198767 record still lists
NCT03198767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which LIK066 is the first listed.
NCT03198767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03198767 about?
NCT03198767 is a clinical study titled "Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066". The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LI...
What is the current status of trial NCT03198767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2017-06-21. Estimated completion is 2017-09-04.
What interventions are being tested in trial NCT03198767?
The interventions under investigation include: LIK066 (DRUG), Carbohydrate 50% (DIETARY_SUPPLEMENT), Carbohydrate 25% (DIETARY_SUPPLEMENT), Carbohydrate 8% (DIETARY_SUPPLEMENT), Carbohydrate 0% (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03198767?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03198767's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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