Functional Abdominal PainPhase 2NCT01675050
A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
A Phase 2 study testing Cyproheptadine and sugar pill in people with Functional Abdominal Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Functional Abdominal Pain
- What is being tested?
- Cyproheptadine and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 8 and 18 years-old
- Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all* of the following:
- Episodic or continuous abdominal pain
- Insufficient criteria for other FGIDs
- No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
- Criteria fulfilled at least once per week for at least 2 months prior to diagnosis
- Written informed consent obtained from the patient/guardian before the initiation of any study-specific procedures
Who cannot join
- Age < 8 years-old or Age >18 years-old
- Child or parent are non-English speakers
- Child is using other CNS depressants (cyproheptadine causes drowsiness, and may enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates, Droperidol, Hydroxyzine, Alcohol)(29)
- Child has a history of hypersensitivity to Cyproheptadine products
- Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan, Parnate) (can cause a prolonged or intensified anticholinergic effect)
- Child was treated with Cyproheptadine in the past 4 weeks
Show all 16Show fewer
- Child is currently using anticholinergic (can cause an additive anticholinergic effect e.g. Pramlintide)
- Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)
- Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine
- Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice versa.
- Child has a personal history of glaucoma
- Child has asthma (can cause thickening of bronchial secretions) (27,28)
- History of liver dysfunction/disease (can cause hepatitis)
- History of cardiac disease (not specific to Cyproheptadine, antihistamines have been associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).
- Females who are known to be pregnant will also be excluded. All females who are of child bearing age, or are already menstruating will perform a urine pregnancy test before enrolling.
- Any children who have difficulties swallowing tablets will receive teaching on how to swallow tablets. If they are still unable to do so, they will not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Functional Abdominal Pain
- Being tested
- Cyproheptadine, sugar pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyproheptadineDrug
Also called Periactin
4 weeks of cyproheptadine or placebo with crossover to the other
sugar pillDrug
Also called placebo
4 weeks of cyproheptadine or placebo with crossover to the other
| Study group | Role | What they receive |
|---|---|---|
| Cyproheptadine first then Placebo | Experimental | 4 weeks of cyproheptadine or placebo with crossover to the other Receives: Drug: Cyproheptadine; Drug: sugar pill |
| Sugar Pill first then Cyprotheptadine | Experimental | 4 weeks of cyproheptadine or placebo with crossover to the other Receives: Drug: Cyproheptadine; Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
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.
Measured: at 4 weeks of cyproheptadine or placebo treatment
Secondary outcomes (1)
Abdominal Pain
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Due to the wide availability of the drug in clinical practice, it was impossible to recruit adequate numbers for scientific power.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Abdominal PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismaeel Hashemi, University of Michigan
- Investigators
- Ismaeel Hashemi, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675050
- Sponsor's protocol ID
- HUM00056045
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2012
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT01675050
- Acronym / sponsor ID
- HUM00056045
- Conditions
- Functional Abdominal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the wide availability of the drug in clinical practice, it was impossible to recruit adequate numbers for scientific power.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Posted 21 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyproheptadine first then Placebo | Experimental | Drug: Cyproheptadine, Drug: sugar pill4 weeks of cyproheptadine or placebo with crossover to the other |
| Sugar Pill first then Cyprotheptadine | Experimental | Drug: Cyproheptadine, Drug: sugar pill4 weeks of cyproheptadine or placebo with crossover to the other |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 8 and 18 years-old
- Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all* of the following:
- Written informed consent obtained from the patient/guardian before the initiation of any study-specific procedures
Key exclusion criteria (16 listed)
- Age < 8 years-old or Age >18 years-old
- Child or parent are non-English speakers
- Child is using other CNS depressants (cyproheptadine causes drowsiness, and may enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates, Droperidol, Hydroxyzine, Alcohol)(29)
- Child has a history of hypersensitivity to Cyproheptadine products
- Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan, Parnate) (can cause a prolonged or intensified anticholinergic effect)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyproheptadineAlso: Periactin4 weeks of cyproheptadine or placebo with crossover to the other | Drug | Cyproheptadine first then Placebo, Sugar Pill first then Cyprotheptadine |
| sugar pillAlso: placebo4 weeks of cyproheptadine or placebo with crossover to the other | Drug | Cyproheptadine first then Placebo, Sugar Pill first then Cyprotheptadine |
Primary outcome
Pressure Pain Threshold
Time frame: 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.
1 secondary outcome
Abdominal Pain
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismaeel Hashemi, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyproheptadine and sugar pill in people with Functional Abdominal Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: at 4 weeks of cyproheptadine or placebo treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.