Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

StatusCompleted
PhasePhase 2
SponsorAbbVie
Started

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Record History

The 50 most recent of 63 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 272 participants (planned 95)
    • Primary completion date changed from estimate of Dec 2026 to Aug 17, 2026
    • Eligibility criteria expanded, about 30 words
    • Study sites revised (46)
  2. Study sites revised (46)v62
  3. Site details revised at 1 of 46 sitesv61
  4. Study sites revised (46)v60
  5. Site details revised at 1 of 46 sitesv59
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 42 to 46
    • Primary and study completion dates: Dec 14, 2026 to Dec 2026
    v58
  2. Site details revised at 4 of 42 sitesv57
  3. Re-verified, no change to tracked fieldsv56
  4. Primary and study completion dates: Dec 15, 2026 to Dec 14, 2026
    • Study sites revised (42)
    v55
  5. Lead sponsor: Allergan to AbbViev54 Show 4 more changesShow less
    • Primary and study completion dates: Dec 15, 2023 to Dec 15, 2026
    • Enrollment target: 120 to 95
    • Eligibility criteria shortened, about 113 words
    • Site details revised at 1 of 42 sites
  6. Study sites: 41 to 42v53
  7. Study sites: 38 to 41v52
  8. Study sites: 33 to 38v51
  9. Study sites: 26 to 33v50
  10. Site details revised at 1 of 26 sitesv49
  11. Primary and study completion dates: Aug 28, 2023 to Dec 15, 2023v48
  12. Study sites: 46 to 26v47
  13. Site details revised at 1 of 46 sitesv46
  14. Site details revised at 1 of 46 sitesv45
  15. Site details revised at 2 of 46 sitesv44
  16. Site details revised at 1 of 46 sitesv43
  17. Study sites: 47 to 46
    • Primary completion date: Jul 25, 2023 to Aug 28, 2023
    • Study completion date: Aug 17, 2023 to Aug 28, 2023
    v42
  18. Site details revised at 1 of 47 sitesv41
  19. 2 versions Re-verified since Feb 24, 2023, no change to tracked fieldsv39-v40
  20. Site details revised at 1 of 47 sitesv38
  21. Study sites: 46 to 47v37
  22. Re-verified, no change to tracked fieldsv36
  23. Site details revised at 1 of 46 sitesv35
  24. Site details revised at 1 of 46 sitesv34
  25. Site details revised at 2 of 46 sitesv33
  26. Study sites: 49 to 46v32
  27. Site details revised at 1 of 49 sitesv31
  28. Site details revised at 1 of 49 sitesv30
  29. Site details revised at 1 of 49 sitesv29
  30. Re-verified, no change to tracked fieldsv28
  31. Study sites: 51 to 49v27
  32. Re-verified, no change to tracked fieldsv26
  33. Site details revised at 1 of 51 sitesv25
  34. Re-verified, no change to tracked fieldsv24
  35. Site details revised at 1 of 51 sitesv23
  36. Study sites revised (51)v22
  37. Primary completion date: Jul 28, 2023 to Jul 25, 2023
    • Site details revised at 1 of 51 sites
    v21
  38. Study sites: 53 to 51v20
  39. Site details revised at 1 of 53 sitesv19
  40. Primary completion date: Jan 1, 2023 to Jul 28, 2023
    • Study sites: 64 to 53
    • Study completion date: Feb 6, 2023 to Aug 17, 2023
    v18
  41. Study sites: 60 to 64v17
  42. Study sites revised (60)v16
  43. Trial status: Active, Not Recruiting to Recruitingv15 Show 4 more changesShow less
    • Primary completion date: Jan 25, 2021 to Jan 1, 2023
    • Study sites: 39 to 60
    • Study completion date: Feb 8, 2021 to Feb 6, 2023
    • Study description shortened, about 6 words
  44. Study Status, Study Descriptionv14
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.
Trial Details
NCT Number NCT03339128
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Irritable Bowel Syndrome
Related terms Irritable Bowel Syndrome
Enrollment 272 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov