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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
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.

Condition Intervention Phase
Irritable Colon
Fecal Urgency
Irritable Bowel Syndrome (IBS)
Drug: SB-705498
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • VAS scores to rectal distensions [ Time Frame: pre dose and 6 hrs post dose. ]

Secondary Outcome Measures:
  • Ongoing rectal pain intensity Quality of Life Assessments

Enrollment: 1
Study Start Date: January 2007
Study Completion Date: September 2007

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00461682

United Kingdom
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00461682     History of Changes
Other Study ID Numbers: VRA107438
Study First Received: April 17, 2007
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
TRPV1 antagonist
Fecal Urgency
rectal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 21, 2017