Table 1. Study Characteristics.
QD: Once Daily, BID: Twice Daily, GEBT: Gastric Emptying Breath Test, AEs: Adverse Events, t1/2: Gastric Emptying Half-time, GCSI-DD: Gastroparesis Cardinal Symptom Index - Daily Diary, PAGI-SYM: Patient Assessment of Gastrointestinal Symptoms, s.c.: Subcutaneous Injection, b.i.d.: Twice Daily (alternative form of BID), N/A: Not Applicable
| Study Characteristic | Acosta et al. [7] | Lembo et al. [8] | Camilleri et al. [9] | Camilleri et al. [10] | Fazeli et al. [11] |
| Design Type | Randomized, double-blind, placebo-controlled, parallel-group | 28-day, randomized, double-blind, placebo-controlled | Randomized, double-blind, placebo-controlled phases 2a and 2b | 12-week, randomized, double-blind, placebo-controlled, parallel-group | Randomized, double-blind, placebo-controlled |
| Centers | 2-center (Mayo Clinic) | 27 clinical centers in the U.S. | Multiple clinical centers | U.S., Israel, and Europe | Massachusetts General Hospital |
| Age Range | 18-65 years | 18-75 years | 18-75 years | 18-75 years | Not specified |
| Patient Characteristics | Chronic constipation | Diabetic gastroparesis | Diabetic gastroparesis | Diabetic gastroparesis | Anorexia nervosa with GI symptoms |
| Drug & Dosage | Relamorelin (100 μg QD) | Relamorelin (10 μg BID, 10 μg QD) | Relamorelin (10 µg, 30 µg, 100 µg b.i.d.) s.c. | Relamorelin (10 μg, 30 μg, 100 μg) b.i.d. s.c. | Relamorelin (100 μg QD) |
| Primary Endpoints | Colonic transit at 24h, stool consistency | Gastric emptying half-time (t1/2) | Adverse events, treatment-emergent AEs | Vomiting frequency | Weight change over 4 weeks |
| Secondary Endpoints | Gastric emptying half-time (t1/2) | Daily symptoms of diabetic gastroparesis | Injection site assessments, weight changes, vital signs | Vomiting severity, GEBT T1/2, individual symptoms, GCSI-DD score | Resting energy expenditure, GEBT results, depression, and PAGI-SYM scores |
| Method for Gastric Emptying Study | Scintigraphic method | 13C-spirulina GEBT | N/A | 13C-spirulina GEBT | GEBT with 13C-spirulina platensis meal |
| Timeframe for Gastric Emptying | End of 14-day treatment | On day 28 | N/A | Baseline and at 12 weeks | Baseline and week 4 |