Sb-705498 Rectal Pain Study

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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-blind, placebo-controlled, two-way crossover study. 21 patients with faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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