Trial · NCT01675050
A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
NCT01675050, Phase 2, Terminated, University of Michigan; results first posted 2017-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain. Trials, record NCT01675050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01675050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
- NCT number
- NCT01675050
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Functional Abdominal Pain
- Interventions
- Cyproheptadine, sugar pill
- First posted
- 2012-08-29
- Last updated
- 2017-08-30
- Results first posted
- 2017-06-21
- Limitations and caveats
- Statistical analyses were not conducted due to small sample size. Results should be interpreted with extreme caution.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pressure Pain Threshold | at 4 weeks of cyproheptadine or placebo treatment | 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. |
| Secondary | Abdominal Pain | 10 weeks | Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pressure Pain Threshold | at 4 weeks of cyproheptadine or placebo treatment | kg/cm^2 | MEAN | |
| SECONDARY | Abdominal Pain | 10 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pressure Pain Threshold | All Participants Post Cyproheptadine | 1.15 | Standard Deviation .73 | kg/cm^2 | |
| Pressure Pain Threshold | All Participants Post Placebo | 1.23 | Standard Deviation .39 | kg/cm^2 | |
| Abdominal Pain | All Participants Post Cyproheptadine | 5.25 | Standard Deviation 4.11 | units on a scale | |
| Abdominal Pain | All Participants Post Placebo | 8 | Standard Deviation 2 | units on a scale |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period One Treatment | STARTED | Cyproheptadine First, Then Placebo | 2 | |
| Period One Treatment | STARTED | Sugar Pill First, Than Cyproheptadine | 2 | |
| Period One Treatment | COMPLETED | Cyproheptadine First, Then Placebo | 1 | |
| Period One Treatment | COMPLETED | Sugar Pill First, Than Cyproheptadine | 2 | |
| Period One Treatment | NOT COMPLETED | Cyproheptadine First, Then Placebo | 1 | |
| Period One Treatment | NOT COMPLETED | Sugar Pill First, Than Cyproheptadine | 0 | |
| Wash Out Period | STARTED | Cyproheptadine First, Then Placebo | 1 | |
| Wash Out Period | STARTED | Sugar Pill First, Than Cyproheptadine | 2 | |
| Wash Out Period | COMPLETED | Cyproheptadine First, Then Placebo | 1 | |
| Wash Out Period | COMPLETED | Sugar Pill First, Than Cyproheptadine | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increase Appetite | General disorders | Cyproheptadine | 1 | 4 | |
| other | Increase Appetite | General disorders | Placebo | 1 | 3 | |
| other | Somnolence (Drowsiness) | Nervous system disorders | Cyproheptadine | 2 | 4 | |
| other | Somnolence (Drowsiness) | Nervous system disorders | Placebo | 1 | 3 | |
| other | Dizziness | Nervous system disorders | Cyproheptadine | 1 | 4 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 3 | |
| other | Cold Sweats | Vascular disorders | Cyproheptadine | 1 | 4 | |
| other | Cold Sweats | Vascular disorders | Placebo | 0 | 3 | |
| other | Restless Sleeping Pattern | Psychiatric disorders | Cyproheptadine | 1 | 4 | |
| other | Restless Sleeping Pattern | Psychiatric disorders | Placebo | 0 | 3 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cyproheptadine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Cyproheptadine | 3 | 4 |
| Total, other adverse events | Placebo | 1 | 3 |
| Total, serious adverse events | Cyproheptadine | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cyproheptadine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01675050
GET https://conductscience.org/api/trials/v1/NCT01675050/registered