Best response distribution of 12-week treatment with prucalopride (RESOLOR) in patients with chronic constipation: combined results of three randomised, double-blind, placebo-controlled phase iii trials: Table 1
Bibliographic record
Abstract
Introduction Treatment of severe chronic constipation (CC) is suboptimal. Prucalopride (PRU) is a selective high affinity 5-HT 4 receptor agonist, first representative of new chemical class (dihydro-benzofurancarboxamide compounds), developed for CC treatment. This study evaluates the combined efficacy results of PRU in 3 identical pivotal, randomised, placebo (PLA)-controlled trials. The objective of each trial was to compare the efficacy and safety of a 12-week once daily treatment of 2 or 4 mg PRU with PLA in CC. Methods All 3 trials, 2 in USA and one in Europe, Canada, Australia and South Africa, were of identical design with 3 parallel treatment groups: PLA, PRU 2 mg and PRU 4 mg. A 12-week treatment phase followed a 2-week run-in. For research purposes a most stringent primary end point was selected: the % of patients with an average of ≥3 spontaneous complete bowel movements (SCBM) per week over a 12-week treatment period (ie, normalisation of bowel movements). Clinical benefit could also be present in patients who did not meet this criterion but satisfied other efficacy end points. Patients' best response was derived from (in order of importance): an average increase of ≥ 1 SCBM/week, an improvement of ≥ 1 point on a satisfaction scale (validated PAC-QOL 5-point subscale), an increase of ≥ 1 SBM or an increase of ≥ 1 BM. Table 1 PWE-075 Placebo (N=645) PRU 2 mg (N=640) PRU 4 mg (N=639) n % Cum % n % Cum % n % Cum % ≥3 SCBM/week 73 11.3 11.3 151 23.6 23.6 158 24.7 24.7 Increase avg SCBM ≥1 82 12.7 24.0 115 18.0 41.6 124 19.4 44.1 Impr ≥1 Satisfaction 54 8.4 32.4 92 14.4 55.9 92 14.4 58.5 Increase avg SBM ≥1 106 16.4 48.8 109 17.0 73.0 103 16.1 74.6 Increase avg BM ≥1 64 9.9 58.8 31 4.8 77.8 35 5.5 80.1 Results A total of 1924 ITT patients were included; 89% female, average age 47 years, average duration of constipation 20 years. During the 2-week run-in 57% of the patients had no SCBM. In each individual trial the results for the primary and secondary end points were significantly better for both PRU groups compared to PLA. Thus, in addition to the response on the primary end point almost 75% of patients had clinical benefit from treatment with PRU with at least an increase of ≥ 1 SBM. Conclusion In addition to primary response rates of about 24% with both 2 and 4 mg PRU, another 50% of patients had clinical benefit of at least an increase of ≥ 1 SBM per week.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".