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Sb-705498 Rectal Pain Study

This study has been terminated.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 17, 2007
Last updated: May 31, 2012
Last verified: February 2011

April 17, 2007
May 31, 2012
January 2007
Not Provided
VAS scores to rectal distensions [ Time Frame: pre dose and 6 hrs post dose. ]
VAS scores to rectal distensions pre dose and 6 hrs post dose.
Complete list of historical versions of study NCT00461682 on Archive Site
Ongoing rectal pain intensity Quality of Life Assessments
Same as current
Not Provided
Not Provided
Sb-705498 Rectal Pain Study
A Double-blind, Randomised, Placebo Controlled, Single Dose, Two-period Crossover Study to Investigate the Therapeutic Potential of the TRPV1 Antagonist SB-705498 in Treatment of Subjects With Rectal Hypersensitivity Including Irritable Bowel Syndrome.
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Irritable Colon
  • Fecal Urgency
  • Irritable Bowel Syndrome (IBS)
Drug: SB-705498
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP