Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
gastric capsaicin with heterotopic stimulation/ distraction
Sponsored by
About this trial
This is an interventional diagnostic trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
FD patients:
- Eighty male and female FD patients according to Rome III criteria (Drossman, 2006), aged 18 to 70 years, will be recruited from primary and secondary care via advertisements and our referral networks.
- FD discomfort or pain should be the most prominent symptom.
- Patients must have been off all FD and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start and be able to remain off such medication for the duration of the study period.
Healthy controls:
- Forty male and female healthy volunteers, aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months will be recruited.
Exclusion Criteria:
Exclusion criteria for both FD patients and healthy controls:
- Organic gastrointestinal or other significant systemic disease, including cardiovascular, dermatological, psychiatric, neurological and endocrine diseases. Patients with peptic ulcer scars are also excluded.
- Chronic or acute pain, except related to other functional syndromes (irritable bowel syndrome, chronic pelvic pain, fibromyalgia, migraine).
- H. pylori positive.
- Abdominal surgery, including gastric resection or cholecystectomy (except appendectomy)
- History of brain disease or brain surgery.
- Ongoing treatment with any drugs or need for drugs (or complementary medication) within last 14 days.
- Treatment with any investigational drug during the preceding 30 days.
- Ingestion of spicy, chilli pepper containing meal, or use of capsaicin skin cream in last 48 hours before start of study or any study day.
- Pregnancy or lactation.
- No written informed consent obtained from subject.
Sites / Locations
- National University Hospital
- National University of Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1, FD patients
2,Healthy controls
Arm Description
Eighty male and female FD patients according to Rome III criteria (Drossman, 2006), aged 18 to 70 years, will be recruited from primary and secondary care via advertisements and our referral networks
Forty male and female healthy volunteers, aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months will be recruited.
Outcomes
Primary Outcome Measures
Differences between healthy controls and FD subjects in visceral pain scores.
Secondary Outcome Measures
Full Information
NCT ID
NCT00693407
First Posted
June 5, 2008
Last Updated
January 6, 2014
Sponsor
National University Hospital, Singapore
Collaborators
NMRC, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00693407
Brief Title
Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
Official Title
Activation of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation in Functional Dyspepsia Patients and Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
Collaborators
NMRC, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Visceral hypersensitivity as evidence of central sensory sensitization is evident in many patients with functional disorders such as functional dyspepsia (FD) and irritable bowel syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes. Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal modulation could explain several of the symptom complexes associated with FD and provide a rationale for exploration of new treatments.
The current study was designed to
investigate the gastric sensitivity in FD patients and healthy controls during gastric capsaicin stimulation
assess the endogenous pain inhibitory modulation system in FD patients and healthy controls during heterotopic stimulation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, FD patients
Arm Type
Experimental
Arm Description
Eighty male and female FD patients according to Rome III criteria (Drossman, 2006), aged 18 to 70 years, will be recruited from primary and secondary care via advertisements and our referral networks
Arm Title
2,Healthy controls
Arm Type
Experimental
Arm Description
Forty male and female healthy volunteers, aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months will be recruited.
Intervention Type
Procedure
Intervention Name(s)
gastric capsaicin with heterotopic stimulation/ distraction
Intervention Description
The subjects are randomized to swallow either a capsaicin 0.50mg capsule or an identical placebo capsule with 100ml of water If after 15 minutes pain scores do not reach a minimum level of 30, a further double-blinded capsule of the same content will be swallowed with 100ml of water. This is repeated to a maximum of 8 capusles until pain with VAS >30 is reported.
Primary Outcome Measure Information:
Title
Differences between healthy controls and FD subjects in visceral pain scores.
Time Frame
within 2 hours of Capsaicin challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
FD patients:
Eighty male and female FD patients according to Rome III criteria (Drossman, 2006), aged 18 to 70 years, will be recruited from primary and secondary care via advertisements and our referral networks.
FD discomfort or pain should be the most prominent symptom.
Patients must have been off all FD and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start and be able to remain off such medication for the duration of the study period.
Healthy controls:
Forty male and female healthy volunteers, aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months will be recruited.
Exclusion Criteria:
Exclusion criteria for both FD patients and healthy controls:
Organic gastrointestinal or other significant systemic disease, including cardiovascular, dermatological, psychiatric, neurological and endocrine diseases. Patients with peptic ulcer scars are also excluded.
Chronic or acute pain, except related to other functional syndromes (irritable bowel syndrome, chronic pelvic pain, fibromyalgia, migraine).
H. pylori positive.
Abdominal surgery, including gastric resection or cholecystectomy (except appendectomy)
History of brain disease or brain surgery.
Ongoing treatment with any drugs or need for drugs (or complementary medication) within last 14 days.
Treatment with any investigational drug during the preceding 30 days.
Ingestion of spicy, chilli pepper containing meal, or use of capsaicin skin cream in last 48 hours before start of study or any study day.
Pregnancy or lactation.
No written informed consent obtained from subject.
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National University of Singapore
City
Singapore
ZIP/Postal Code
119742
Country
Singapore
12. IPD Sharing Statement
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Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
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