Trial of Mannitol Cream for Pain Relief After a Long Run

NCT01843088 | Completed Phase 1 DMC

• 1 other identifier: H13-00106
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the following five days. Mannitol and control legs will be chosen at random for each runner. Pain scores before and after cream application will be acquired each day for each leg. Means and standard deviations found will be used to determine the size of a larger study.

Conditions

Pain

Keywords

Pain; exercise; muscle

Outcome Measures

Primary Outcomes (1)

• Change in NRS (Numeric rating scale) pain score

  NRS (Numeric rating scale) pain score from zero, no pain, to 10 worst pain ever. Change in pain score will be measured daily starting on day of race, comparing pain following the race, prior to the first cream application, to the daily scores for the subsequent five days. Pain levels in leg given mannitol cream, and leg given placebo cream will be compared according to the change in their pain scores.

  For six days following run

Secondary Outcomes (1)

• side effects of cream

  For six days, starting on day of race.

Study Arms (2)

Mannitol cream

EXPERIMENTAL

cream containing 25% mannitol, applied as often and as much as needed to one leg ( chosen at random), on the day of a 10 km run, following the run and for five days afterwards

Drug: Mannitol cream

Placebo cream

PLACEBO COMPARATOR

Same carrier cream as that containing the active ingredient, mannitol, but without the active ingredient. Placebo cream to be applied to the painful areas of the other leg, chosen at random, on the day of a 10 km or more race, following the race, and as needed for the five days after the race. It is to be noted that, as almost no mannitol is absorbed through the skin, it is highly unlikely that this would involve the pain levels in the placebo leg.

Drug: Placebo Cream

Interventions

Mannitol cream DRUG

25% mannitol in PENcream (See above) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.

Also known as: Mannitol, PENcream, Commercially available proprietary cream.

Mannitol cream

Placebo Cream DRUG

This is the vehicle only cream (PENcream) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.

Also known as: PENcream, commercially available proprietary cream.

Placebo cream

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• either:
• never ran 10 km or more, or;
• NRS pain level greater than 5/10 in both legs following a 10 km or more run

You may not qualify if:

• no major skin allergies
• no allergy to mannitol

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Dr. Helene Bertrand, University of British Columbia, Department of Family Practice

Vancouver, British Columbia, V7M 2K2, Canada

Location

Related Publications (1)

• Cavone L, Calosi L, Cinci L, Moroni F, Chiarugi A. Topical mannitol reduces inflammatory edema in a rat model of arthritis. Pharmacology. 2012;89(1-2):18-21. doi: 10.1159/000335094. Epub 2012 Jan 10.

  PMID: 22236612 RESULT

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Helene Bertrand, MD, CCFP

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 30, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

CA (1)