Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation

Functional Dyspepsia Clinical Trial

Official title:

Activation of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation in Functional Dyspepsia Patients and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693407
• Other study ID #: D/07/088
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: January 6, 2014
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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

1. investigate the gastric sensitivity in FD patients and healthy controls during gastric capsaicin stimulation

2. assess the endogenous pain inhibitory modulation system in FD patients and healthy controls during heterotopic stimulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Procedure:
• gastric capsaicin with heterotopic stimulation/ distraction
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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	NMRC, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between healthy controls and FD subjects in visceral pain scores.		within 2 hours of Capsaicin challenge	No