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Kindolor Cohort 1 for Chronic Pain

Phase 1

Recruiting

Led By Mark Wallace, MD

Research Sponsored by Lohocla Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male or female volunteer, ages 18-to-55 years, inclusive

Postmenopausal, surgically sterile, or agree to use acceptable birth control if female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose to 48 hours post-dose

Awards & highlights

Study Summary

This trial aims to test Kindolor in healthy adults to find out the safe dose and how the body processes it. Participants will receive Kindolor or a placebo and undergo medical tests to compare the effects.

Who is the study for?

This trial is for healthy adults who can participate in a study to determine the safe dosage of Kindolor, a drug intended for chronic pain management. Participants will be closely monitored through medical tests before and after receiving the medication.Check my eligibility

What is being tested?

The study is testing different doses of Kindolor Tosylate compared to a placebo. The focus is on finding out what dose is safe and how the body processes it. Volunteers are randomly assigned to receive either Kindolor or an inactive substance.See study design

What are the potential side effects?

Since this trial involves healthy volunteers, potential side effects could range from mild reactions at the site of administration to more systemic effects depending on how Kindolor affects individuals differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy adult between 18 and 55 years old.

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I am postmenopausal, surgically sterile, or I agree to use birth control.

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My BMI is between 18 and 32, and I weigh at least 50 kg (110 lbs).

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I can complete all screenings, stay for 3 days and 2 nights for Phase I, and return for a follow-up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose to 48 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose to 48 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose to 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence, Severity and Relationship of Adverse Events [Safety and Tolerability]

Secondary outcome measures

Pharmacokinetic AUCt of Kindolor Tosylate

Pharmacokinetic AUC∞ of Kindolor Tosylate

Pharmacokinetic Cmax of Kindolor Tosylate

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Kindolor Cohort 4Experimental Treatment1 Intervention

Kindolor Tosylate 6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group II: Kindolor Cohort 3Experimental Treatment1 Intervention

Kindolor Tosylate 3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group III: Kindolor Cohort 2Experimental Treatment1 Intervention

Kindolor Tosylate tablet 1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq

Group IV: Kindolor Cohort 1Experimental Treatment1 Intervention

Kindolor Tosylate 1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq

Group V: Placebo ComparatorPlacebo Group1 Intervention

Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,472 Previous Clinical Trials

2,619,590 Total Patients Enrolled

55 Trials studying Chronic Pain

82,928 Patients Enrolled for Chronic Pain

Lohocla Research CorporationLead Sponsor

Mark Wallace, MDPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Kindolor Cohort 1 received approval from the FDA?

"Our research team at Power has appraised the safety of Kindolor Cohort 1 as a level 1 on our scale from 1 to 3. This assessment is due to the trial being in Phase 1, indicating sparse evidence backing its safety and effectiveness."

Answered by AI

Are individuals older than 80 years being enrolled in this study?

"The enrollment criteria for this research study require participants to fall within the age range of 18-55 years. Notably, there are a total of 37 investigations tailored for individuals under 18 and 352 studies aimed at those over 65."

Answered by AI

Am I eligible to enroll in this clinical trial?

"Participants meeting the eligibility criteria must exhibit chronic pain and fall between 18 to 55 years of age. The trial aims to enroll a total of 32 individuals."

Answered by AI

Is the enrollment for this investigation presently open?

"As per clinicaltrials.gov data, this investigation is no longer seeking subjects. Originally uploaded on April 1st, 2024 and last revised on January 29th, 2024. Despite its closure to further participants, there are currently 396 alternative trials open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults

2024. "A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06243835.

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