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
  Purpose

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
Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


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
Intervention Details:
    Drug: SB-705498
    Other Name: SB-705498
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00461682

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00461682     History of Changes
Other Study ID Numbers: VRA107438
Study First Received: April 17, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
TRPV1 antagonist
Fecal Urgency
rectal pain
IBS

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014