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Camicinal · 1 trial · 1 indication
The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84 |
| Camicinal 25mg | EXPERIMENTAL | Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning |
| Camicinal | DRUG | Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning |
Inclusion Criteria: * Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 \[HbA1c\] \<=11.0%) * Male or female between 18 and 80 years of age, inclusive. * Patient has gastroparesis at screening. A patient is eligible if one of the following criteria are met: Gastric half-time of emptying \>upp...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
Camicinal is an investigational small molecule being studied for the treatment of gastroparesis, a condition in which the stomach empties too slowly. It has been evaluated in patients with type 1 and type 2 diabetes who have gastroparesis. Camicinal is not yet approved for any indication and remains in clinical development.
Camicinal targets MLNR, the motilin receptor. It acts as an agonist at this receptor. By activating the motilin receptor, camicinal is designed to stimulate gastrointestinal motility, which is relevant to conditions like gastroparesis where stomach emptying is delayed.
Camicinal is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating camicinal in gastroparesis.
Camicinal is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. The Phase 2 program for camicinal in gastroparesis has been completed, and the drug remains investigational.
Camicinal has been studied in a completed Phase 2 trial, NCT02210000, titled A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis. The trial enrolled 114 participants in the United States and was randomized, double-blind, and placebo-controlled.