Last updated: 08/03/2020 14:50:04
Sb-705498 Rectal Pain Study
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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:
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
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
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
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
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
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
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
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
Symptom scoring and Quality of Life assessments over period
Timeframe: Approximately up to 3 months
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
Interventions:
Enrollment:
Not applicable
Primary completion date:
2007-18-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Colon
Product
SB705498
Collaborators
Not applicable
Study date(s)
January 2007 to September 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Female/male aged 18-65.
- Women of child bearing potential must use an effective method of contraception
- Any clinical or biological abnormality found at screen (other than those related to the disease under investigation)
- History of alcohol, substance or drug abuse
Inclusion and exclusion 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2007-18-09
Actual study completion date
2007-18-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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