Clinical trial NCT00461682: Sb-705498 Rectal Pain Study
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Colon
Keywords: TRPV1 antagonist
Fecal Urgency
rectal pain
IBS
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period
timeFrame: Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period
Secondary outcomes:
measure: 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
timeFrame: Baseline (pre-dose) and up to 6 h post-dose of each treatment period
measure: 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
timeFrame: Baseline (pre-dose) and 6h post-dose of each treatment period
measure: 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
timeFrame: Baseline (pre-dose) and up to 0-6 h of each treatment period
measure: 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
timeFrame: Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period
measure: Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period
timeFrame: Baseline (pre-dose) and upto 0-6h post-dose for each treatment period
measure: Contact Heat-evoked Potentials (CHEPs) - Optional, Assessed Pre-dose and 6h Post-dose of Each Treatment Period
timeFrame: Baseline (pre-dose) and 6h post-dose of each treatment period
measure: Number of Defecations Over 24h and Over 1 Week Following a Dose of SB-705498 (Monitored Using Bristol Stool Scoring Diary Kept 1 Week Pre- and 1 Week Post-dose)
timeFrame: 7 days pre-dose and 7 days post-dose of each treatment period
measure: Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) Calculated Over Approximately 10 Days Pre- and Post-dose
timeFrame: 10 days pre-dose and post-dose of each treatment period
measure: Symptom Scoring and Quality of Life Assessments Over Period
timeFrame: Approximately up to 3 months
measure: Average Daily Pain Scores at Baseline (Pre-dose), 1, 2, 3, 4, 5 and 6h Post-dose for Each Treatment Period
timeFrame: At Baseline (pre-dose) and each hour post-dose of each treatment period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: