Sb-705498 Rectal Pain Study

NCT00461682 | Terminated Phase 2 Results

• 1 other identifier: VRA107438
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Colon

Keywords

TRPV1 antagonist; Fecal Urgency; rectal pain; IBS

Outcome Measures

Primary Outcomes (1)

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

  This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain.

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

Secondary Outcomes (10)

• Visual Analogue Scores for Rectal Distensions for Gas, Urgency to Defecate and Discomfort at Pre-dose and 6 h Post-dose of Each Treatment Period

  Baseline (pre-dose) and up to 6 h post-dose of each treatment period

• Rectal Sensory Thresholds to Thermal Stimulation (Contact Heat Device, Values Reported as in Study) at Pre-dose and 6h Post-dose of Each Treatment Period

  Baseline (pre-dose) and 6h post-dose of each treatment period

• Peak Pain Intensity Difference (PPID6), as Derived From Maximum Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h of Each Treatment Period

  Baseline (pre-dose) and up to 0-6 h of each treatment period

• Pain Intensity Difference (SPID6), as Derived From Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h Post-dose of Each Treatment Period

  Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period

• Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period

  Baseline (pre-dose) and upto 0-6h post-dose for each treatment period

Interventions

SB-705498 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

SB 705498

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: January 26, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 20, 2018
• Results First Posted: May 8, 2017

Record last verified: 2018-07

Locations

GB (1)