Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation

NCT00693407 | Completed DMC

• 1 other identifier: D/07/088
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

1. 1.investigate the gastric sensitivity in FD patients and healthy controls during gastric capsaicin stimulation
2. 2.assess the endogenous pain inhibitory modulation system in FD patients and healthy controls during heterotopic stimulation

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Differences between healthy controls and FD subjects in visceral pain scores.

  within 2 hours of Capsaicin challenge

Study Arms (2)

1, FD patients

EXPERIMENTAL

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

Procedure: gastric capsaicin with heterotopic stimulation/ distraction

2,Healthy controls

EXPERIMENTAL

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.

Procedure: gastric capsaicin with heterotopic stimulation/ distraction

Interventions

gastric capsaicin with heterotopic stimulation/ distraction PROCEDURE

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.

1, FD patients; 2,Healthy controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• NMRC, Singapore: collaborator

Study Sites (2)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

National University of Singapore

Singapore, Singapore, 119742, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

SG (2)