A Phase 3 interventional study of Itopride and Placebo in Heartburn, sponsored by Forest Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-09.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 3, Interventional, and Treatment
Among 76 studies in Heartburn with a site in United States — 5 open to participants now, 7 under way, 1 of them phase 3. Heartburn · United States.
Among the 76 studies in Heartburn with a site in United States, this one is the 45th largest by enrollment of the 66 interventional ones that give a count, is one of 8 that started in 2006, is one of 18 in phase 3, and was the 11th registered.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
Browse Heartburn studies →5 of the 76 studies in Heartburn with a site in United States are open now. Recruiting first, the newest first:
Arizona State University · Sites in United States
Ages 18+
Peach Perfect · Sites in United States
Ages 18–60
Phathom Pharmaceuticals, Inc. · Sites in United States
Ages 15–50 · Women only
Mayo Clinic · Sites in United States
Ages 18+
McMaster University · Sites in United States, Canada
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Heartburn studies recruiting now, 5 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
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76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 13 · Phase 3 20 · Phase 4 8
First in 1999; this study’s year is marked. 8 started in 2006.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Median enrollment 98 across the 66 interventional studies, 414 across the 10 observational. Of the 63 that completed or were terminated, 28 (44%) have results posted.
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45 of 76 have an industry lead sponsor. The 10 most frequent:
Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
AbbVie has 1 study filed under Heartburn — fewer than ten, so there is no comparison to draw.
3 of the studies in Heartburn with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01696734Phase 3M.D. Anderson Cancer CenterDomperidone in Treating Patients With Gastrointestinal Disorders | 2027-10-31 |
| NCT05976165Mayo ClinicA Study of Breath Testing for Small Intestinal Bacterial Overgrowth | 2027-01-01 |
| NCT07927296Arizona State UniversityVinegar and Heartburn | 2027-05-15 |
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Among the 76 studies in Heartburn with a site in United States, from their registry updates:
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The purpose of this study is to evaluate the effects of itopride in patients with heartburn.
Inclusion Criteria:
24-hour pH Monitoring
Time frame: after 5 days of treatment
The record gives a start of Oct 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Itopride