TerminatedPhase 2

Sb-705498 Rectal Pain Study

United Kingdom1 participantsStarted 2007-01-26

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period

Timeframe: Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period

Trial details

NCT IDNCT00461682

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-09-01

Results submitted2017-03-27