Dataset Information

Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.

ABSTRACT: OBJECTIVES:Compared with pain-free controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms. MATERIALS AND METHODS:Fifty-one FM patients were randomized to daily oral ketotifen 2 mg bid (n=24) for 8 weeks or placebo (N=27). Mean age of patients was 51.2 years (SD=8.4); 88% were female and 88% were white; 22% were taking concomitant opiates; and mean pressure pain sensitivity (range, 0 to 20) was 10.0 (0.4). At study entry, the weekly average pain intensity was 6.4 (1.1) and the mean score on the Revised Fibromyalgia Impact Questionnaire-Revised was 66.8 (14.0). RESULTS:We found no statistically significant treatment group differences from baseline in either group for the 2 primary measures: weekly average pain intensity (ketotifen -1.3 [1.9] vs. placebo -1.5 [1.9], P=0.7); and Fibromyalgia Impact Questionnaire-Revised score (-12.1 [19.5] vs. -12.2 [18.1], P=0.9). No secondary outcome measures (Brief Pain Inventory pain intensity and pressure pain sensitivity) reached statistical significance; results did not differ in the intent-to-treat and completer analyses. Other than transient sedation (6 [28.6%] vs. 1 [4.0%]), ketotifen was well tolerated. DISCUSSION:The study results question whether skin mast cells play a major role in the pathogenesis of FM. However, given the role of mast cells in peripheral and central nociception, and the minimal side effects of ketotifen, a randomized clinical trial using increasing doses of ketotifen may be warranted.

SUBMITTER: Ang DC

PROVIDER: S-EPMC4417653 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.

Ang Dennis C DC Hilligoss Janna J Stump Timothy T

The Clinical journal of pain 20150901 9

<h4>Objectives</h4>Compared with pain-free controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms.<h4>Materials and methods</h4>Fifty-one FM patients were randomized to daily oral ketotifen 2 mg bid (n=24) for 8 weeks or placebo (N=27). Mean age of patients was 51.2 years (SD=8.4); 88% were female and 88% were white; 22 ...[more]

PMID: 25370135

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Project description:Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia.This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ?4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure.Overall, 393 patients were randomized to receive either duloxetine (n?=?196) or placebo (n?=?197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups.Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia.ClinicalTrials.gov Identifier: NCT01552057 . Registered 9 March 2012.

Project description:BACKGROUND:Injuries and resulting stiffness around joints, especially the elbow, have huge psychological effects by reducing quality of life through interference with normal daily activities such as feeding, dressing, grooming, and reaching for objects. Over the last several years and through numerous research results, the myofibroblast-mast cell-neuropeptide axis of fibrosis had been implicated in post-traumatic joint contractures. Pre-clinical models and a pilot randomized clinical trial (RCT) demonstrated the feasibility and safety of using Ketotifen Fumarate (KF), a mast cell stabilizer to prevent elbow joint contractures. This study aims to evaluate the efficacy of KF in reducing joint contracture severity in adult participants with operately treated elbow fractures and/or dislocations. METHODS/DESIGN:A Phase III randomized, controlled, double-blinded multicentre trial with 3 parallel groups (KF 2?mg or 5?mg or lactose placebo twice daily orally for 6?weeks). The study population consist of adults who are at least 18?years old and within 7?days of injury. The types of injuries are distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2?U1 and/or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included). A stratified randomization scheme by hospital site will be used to assign eligible participants to the groups in a 1:1:1 ratio. The primary outcome is change in elbow flexion-extension range of motion (ROM) arc from baseline to 12?weeks post-randomization. The secondary outcomes are changes in ROM from baseline to 6, 24 & 52?weeks, PROMs at 2, 6, 12, 24 & 52?weeks and impact of KF on safety including serious adverse events and fracture healing. Descriptive analysis for all outcomes will be reported and ANCOVA be used to evaluate the efficacy KF over lactose placebo with respect to the improvement in ROM. DISCUSSION:The results of this study will provide evidence for the use of KF in reducing post-traumatic joint contractures and improving quality of life after joint injuries. TRIAL REGISTRATION:This study was prospectively registered (July 10, 2018) with ClinicalTrials.gov reference: NCT03582176.

Dataset Information

Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.

Publications

Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.

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