Characteristics of Clinical Studies on Gastroparesis Registered in ClinicalTrials.gov-A Cross-Sectional Analysis.

Background: Gastroparesis (GP) is a chronic gastrointestinal motility disorder marked by delayed gastric emptying in the absence of mechanical obstruction. Despite its debilitating nature and high unmet therapeutic need, the clinical research landscape in GP remains underexplored. This study aimed to assess the trends, characteristics, and funding patterns of GP-related clinical trials registered on ClinicalTrials.gov (CTG).

Methods: A cross-sectional analysis was conducted using data from CTG between September 27, 2007, and April 30, 2024. Trials were identified using specific search terms and categorized by study type, phase, funding source, and status. Comparisons were made between GP trials and all registered trials on CTG. Statistical analyses included frequency distributions and odds ratios (OR) with 95% confidence intervals (CI).

Results: A total of 249 GP studies were registered, comprising only 0.059% of all CTG studies, with 68 ongoing as of April 2024. Interventional studies represented 77.1% of all GP trials, but this proportion declined significantly in ongoing studies (OR 0.23; 95% CI: 0.13-0.41). Registry-based studies increased significantly among ongoing trials (OR 3.4; 95% CI: 1.56-7.57). Industry and NIH-funded trials accounted for 27.3% and 8.4%, respectively, while the majority (77.1%) were funded by other sources. Completion rates for GP studies were significantly lower (39.8%) than the overall CTG average (50.3%), and GP trials had higher discontinuation (18.5% vs. 8.8%) and unknown status rates (41.8% vs. 14.8%). Ongoing GP studies also showed a marked decline in early-phase trials, particularly Phase 1 (OR 0.05; 95% CI: 0.03-0.08), while Phase 2 studies were more common when compared with all CTG studies.

Conclusion: Despite increasing overall research activity on CTG, clinical trials in GP have remained relatively stagnant, with fewer interventional and early-phase trials in recent years. The high discontinuation and low completion rates, along with limited industry sponsorship, highlight significant barriers to advancing GP therapeutics. Attention is needed from the industry and policymakers to bring focus on the development of therapeutic solutions for improved clinical outcomes.