Sb-705498 Rectal Pain Study (NCT00461682) | Clinical Trial Compass
TerminatedPhase 2
Sb-705498 Rectal Pain Study
United Kingdom1 participantsStarted 2007-01-26
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period