Evidence map›Paper›PMID 20428949›Full record

Trial reportDigestive diseases and sciences2010

Efficacy and safety of prucalopride in patients with chronic noncancer pain suffering from opioid-induced constipation.

Cornelius E J Sloots, An Rykx, Marina Cools, Rene Kerstens, Martine De Pauw

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 5 pooled it
7.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 5 syntheses or guidelines pooled it, 133 citations in OpenAlex.

  1. MASCC recommendations on the management of constipation in patients with advanced cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Prucalopride: For functional constipation only?Techniques in coloproctology · 2016
    Pooled it
  6. Trial
  7. Inadequate management of opioid-induced constipation in European cancer pain patients: results of a real-world, multicentre, observational study ("E-StOIC").Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Observational
  8. Constipation in Cancer Patients - an Update of Clinical Evidence.Current treatment options in oncology · 2022
    Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Opioid-induced bowel dysfunction: suggestions from a multidisciplinary expert Board.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Cornelius E J SlootsDepartment of Pediatric Surgery, Erasmus Medical Center, Rotterdam, The Netherlands. c.sloots@erasmusmc.nl
An Rykx
Marina Cools
Rene Kerstens
Martine De Pauw
AZ Turnhout · BEErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpioid-induced constipation (OIC) has negative effects on quality of life (QOL). Prucalopride is a new, selective 5-HT(4) agonist and enterokinetic with strong clinical data in chronic constipation. This study investigated the efficacy, safety, and tolerability of prucalopride in patients with noncancer pain and OIC.

methodsA phase II, double-blind, placebo-controlled study of 196 patients randomized to placebo (n = 66), prucalopride 2 mg (n = 66) or 4 mg (n = 64), for 4 weeks, was carried out. The primary endpoint was the proportion of patients with increase from baseline of ≥ 1 spontaneous complete bowel movement (SCBM)/week. Secondary endpoints [proportion of patients with ≥ 3 SCBM/week, weekly frequency of (SC)BM, severity of constipation, and efficacy of treatment], adverse events (AEs), and safety parameters were also monitored.

resultsMore patients had an increase from baseline of ≥ 1 SCBM per week (weeks 1-4) in the prucalopride groups [35.9% (2 mg) and 40.3% (4 mg)] versus placebo (23.4%), reaching statistical significance in week 1. Over weeks 1-4, more patients in the prucalopride groups achieved an average of ≥ 3 SBM per week versus placebo (60.7% and 69.0% versus 43.3%), reaching significance at week 1. Prucalopride 4 mg significantly improved patient-rated severity of constipation and effectiveness of treatment versus placebo. Patient Assessment of Constipation-Symptom (PAC-SYM) total scores and Patient Assessment of Constipation-Quality of Life (PAC-QOL) total and satisfaction subscale scores were improved. The most common AEs were abdominal pain and nausea. There were no clinically relevant differences between groups in vital signs, laboratory measures or electrocardiogram parameters.

conclusionIn this population with OIC, prucalopride improved bowel function and was safe and well tolerated.

Indexed as

Abdominal PainAdultAgedAged, 80 and overAnalgesics, OpioidBenzofuransConstipationDouble-Blind MethodDrug Therapy, CombinationElectrocardiographyFemaleHumansLaxativesMaleMiddle AgedPlacebo EffectAnalgesics, OpioidBenzofuransLaxativesprucaloprideSerotonin Receptor Agonists

Identifiers

PMID20428949
PMCPMC2943574
OpenAlexW2061136386

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.