Pain Relief for Irritable Bowel Syndrome

TLS is collaborating with NV Rose to develop a non-opioid analgesic to alleviate pain episodes associated with IBS.  All IBS sub-types will be considered for this study; IBS-D, IBS-C and IBS-M/A. We are focusing on pain episodes – whatever the type and duration. This trial study will evaluate the analgesic efficacy of ROSE-010 compared to placebo and will evaluate pain response to treatment. 

We are seeking feedback in key areas of the trial, including:
  

  • Primary and Secondary Endpoints

  • Inclusion/Exclusion Criteria

  • Nature and Severity of Symptoms

  • Study Population and Enrollment Criteria

  • Duration of Trial

  • Mode of Drug Delivery

  • Trial Design

  • Safety/Regulatory Concerns

  • Use of Wearable Devices and Video Visits

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An Opportunity for Publication

All participants will be able to review and comment on drafts of the protocol as they are produced. Participating in this crowdsourcing project also enters you into a friendly competition among the research community. When we identify the researchers who have provided the best input for a certain section of the survey, we will name up to three winners of the section.

By winning a section, researchers will enter into a discussion with the TLS study team on how to draft the best protocol. When this protocol is published, the top researchers will have co-authorship rights and an ongoing say into the design and implementation of the trial.

Protocol Builder Results

Rationale

How can we make clinical trials in IBS more convenient for the patient.? We're gathering the opinions from patients and researchers on these proposed approaches, in order to achieve the best possible trial outcome.

Our goal is to assess patient expectations for remote measurement techniques in clinical trials for IBS, and we'd also like to evaluate patient willingness and levels of trust in this new type of clinical trial.

We're seeking input from researchers about various aspects of the trial in order to ensure optimized results and patient experience.

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Population

Should this trial be open to all types of IBS?

We are asking patients to share information about their backgrounds with IBS, which will be aggregated so that we can make the trial as comprehensive as possible. 

We are asking for researcher input regarding demographic criteria in order to ensure the patient population is properly suited to the trial. 

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Dose

In order to optimize the trial design, we ask for feedback from both patients and researchers regarding the dosing schedule.

We are interested in patient willingness to take medication through various methods.

We are seeking researcher feedback on the dosing schedule as it relates to the overall trial design. 

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Telemedicine

The primary objective of this study is to evaluate the effectiveness and ease-of-use of telemonitoring technology and techniques in assessing standard clinical endpoints in IBS.

We want to hear about patient experience with various telemedicine devices, as well as their level of comfort using such devices in a medical context. 

We are seeking researcher feedback regarding the efficacy of using telemedicine devices in a clinical trial in terms of patient convenience and safety.

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Safety

We are seeking input from Patients and Researchers regarding trial safety in order to ensure patient comfort and safety at all times.

We want to make sure that we address patients’ concerns about safety and comfortability with this new type of trial design.

We ask researchers to provide insight into trial safety, especially in the context of telemedicine.  

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Regulatory

In order to ensure regulatory compliance, we ask both patients and researchers to address any regulatory/ethical concerns they may have.

We want patients to share any ethical concerns they might have about this trial, especially those related to telemedicine devices and data privacy/security.

We are looking for researcher insight that will allow us to best optimize our regulatory strategy for this trial.

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