Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

NCT00548574 | Completed Phase 3

• 1 other identifier: SPD476-302
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline)

  8 weeks

Secondary Outcomes (4)

• Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score

  8 weeks

• Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA

  8 weeks

• Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score

  8 weeks

• Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score

  8 weeks

Interventions

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine DRUG

Also known as: LIALDA

Mesalazine DRUG

Also known as: ASACOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology
• females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

You may not qualify if:

• subjects with relapsing UC who were in relapse for \> 6 weeks prior to baseline
• subjects who relapsed on maintenace therapy with doses of mesalazine =\> 2g/day
• subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of \> 2g/day
• subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
• subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
• subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Imelda General Hospital Dept of Gastroenterology

Bonheiden, Belgium

Location

Related Publications (1)

• Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.

  PMID: 17241860 RESULT

Related Links

• FDA-approved labelling information, US only
• FDA Recall information

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: December 4, 2003
• Primary Completion: October 20, 2004
• Study Completion: October 20, 2004
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

BE (1)