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NCT01675050 · ClinicalTrials.gov registry record · Phase 2
A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
A Phase 2 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01675050 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 4 participants.
The verdict
NCT01675050, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being
Interventions
- DRUG Cyproheptadine
- DRUG sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01675050
The ClinicalTrials.gov registry entry for NCT01675050 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cyproheptadine is the first listed.
NCT01675050 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01675050 about?
NCT01675050 is a clinical study titled "A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain". The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain a...
What is the current status of trial NCT01675050?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2012-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01675050?
The interventions under investigation include: Cyproheptadine (DRUG), sugar pill (DRUG).
Who is sponsoring clinical trial NCT01675050?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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