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Completed

NCT Number: NCT00151892

Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Italiano de Buenos Aires, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
  • female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion criteria

  • proctitis
  • previous resective colonic surgery
  • Crohn's disease
  • hypersensitivity to salicylates
  • moderate/severe renal impairment

Treatment and study plan

SPD476

Drug

2.4 g/day Once Daily (QD)

Other names: Lialda, mesalazine, mesalamine, MMX mesalamine

Asacol

Drug

1.6g/day administered 800 mg Twice Daily (BID)

Other names: mesalamine

Primary outcomes

  1. Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months

    Time frame: 6 Months

    Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].

Secondary outcomes

  1. Withdrawal Due to Relapse of UC

    Time frame: Over 6 Months

    Relapse is defined as withdrawal from the study due to lack of efficacy.

  2. Endoscopic Remission of UC With No or Mild Symptoms at 6 Months

    Time frame: 6 Months

    Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

  3. Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months

    Time frame: Baseline and 6 months

    The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.

  4. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score

    Time frame: 6 Months

    Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2005
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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