CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 81 enrolled
Drug / intervention
Citalopram +1 moredrug
Likely dose
Citalopram 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00962039
NCT00962039Phase 3Completed

Anxiety and Recurrent Abdominal Pain in Children

John V. Campo, M.D.·interventional·Posted Aug 19, 2009·Updated Jun 11, 2020

In Brief

A Phase 3 clinical trial evaluating Citalopram and Placebo for Abdominal Pain and Anxiety. Completed, enrolled 81 participants across 1 site.

Detailed Summary

This study aims to determine whether citalopram is a useful, well-tolerated, and safe treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The study hypothesis is that citalopram will be better than placebo in producing clinical improvement and reductions in abdominal pain. It is also hypothesized that citalopram and placebo will not differ in terms of safety and tolerability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2009
Enrollment StartJul 1, 2004
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.9 years ago

Interventions

Citalopramdrug

Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.

Placebodrug

Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.