Sb-705498 Rectal Pain Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-26

Study Completion Date

2007-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia

NCT01058642

Postherpetic Neuralgia

TERMINATED PHASE2

A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults

NCT05721287

Pain Acute Pain

COMPLETED PHASE1

A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers

NCT05496205

Osteoarthritis Pain Post Herpetic Neuralgia +3 more

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

NCT05174013

Pain

COMPLETED PHASE1

The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain

NCT00376454

Neuropathic Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Colon

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB-705498

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No