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Sb-705498 Rectal Pain Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00461682
First received: April 17, 2007
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

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 ClinicalTrials.gov 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Irritable Colon
  • Fecal Urgency
  • Irritable Bowel Syndrome (IBS)
Drug: SB-705498
Other Name: SB-705498
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00461682
VRA107438
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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