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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: Clinical Trial Phase 2 study, sponsored by University of Michigan.
NCT01675050 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
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 |
Why NCT01675050 stopped before completion
NCT01675050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyproheptadine is the first listed.
NCT01675050 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01675050's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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