Status:
TERMINATED
Sb-705498 Rectal Pain Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Irritable Colon
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
SB-705498 has demonstrated efficacy in several preclinical and human experimental pain models. This study will investigate the efficacy of SB-705498 in patients with rectal pain. This will be a double...
Eligibility Criteria
Inclusion
- Female/male aged 18-65.
- Women of child bearing potential must use an effective method of contraception
- Faecal urgency as defined by Chan
- ECG, which has no abnormalities
- Normal Clinical labs
- Informed consent and understand protocol requirements
- IBS subjects: Has irritable bowel syndrome (IBS) as defined by Rome II criteria
- Rectal hyperalgesia
Exclusion
- Any clinical or biological abnormality found at screen (other than those related to the disease under investigation)
- History of alcohol, substance or drug abuse
- Uncontrolled hypertension
- A history or presence of cardiovascular risk factors
- Participation in a trial within 3 months before the start of the study
- History of allergy
- Unable to withdraw from analgesic medications for their rectal hyperalgesia (opioid-dependent patients can be included if they are willing to withdraw from their opiate medication
Key Trial Info
Start Date :
January 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00461682
Start Date
January 26 2007
End Date
September 1 2007
Last Update
August 20 2018
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, W12 0NN